Trial · NCT03187301
A Cardiac Safety Study of an Investigational Drug to See How if Affects the Heart in People With Parkinson's Disease Complicated by Motor Fluctuations "OFF" Episodes
NCT03187301, Phase 2, Completed, Sumitomo Pharma America, Inc.; results first posted 2020-08-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Cardiac Safety Study of an Investigational Drug to See How if Affects the Heart in People With Parkinson's Disease Complicated by Motor Fluctuations "OFF" Episodes. Trials, record NCT03187301. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03187301
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Cardiac Safety Study of an Investigational Drug to See How if Affects the Heart in People With Parkinson's Disease Complicated by Motor Fluctuations "OFF" Episodes
- NCT number
- NCT03187301
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 48 participants, actual
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Conditions
- Parkinson's Disease, Off Episodes of Parkinson Disease
- Interventions
- APL-130277, Placebo, Moxifloxacin
- First posted
- 2017-06-14
- Last updated
- 2020-08-10
- Other registries' IDs
- eudract:2016-001762-29
- Results first posted
- 2020-08-10
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time-Matched Change From Baseline in QTc, Placebo-Adjusted and Corrected for Heart Rate Based on the Fridericia Correction Method (QTcF) Using Delta Delta Method (ΔΔQTcF): Comparison Between APL-130277 and Placebo (Central Tendency Analysis) | Baseline to 15, 30, 45, 60 mins and 2, 3, and 4 hours post-dose for each of the 3 treatment period dosing visits. | For the primary central tendency analysis, the changes from baseline (ΔQTcF) were compared between APL-130277 and placebo (ΔΔQTcF). Baseline was defined as the mean of the 9 ECGs (3 sets of triplicate ECGs) recorded at baseline (P1V1). In case any of the 9 ECGs were missing, the baseline was defined as the mean of the available baseline values. The post-dose ECGs were evaluated at 15, 30, 45 and 60 minutes (mins) and 2, 3 and 4 hours post-dose at each of the 3 treatment period dosing visits during the Randomized Crossover Assessment Phase. For each of the time points, an average value was calculated based on the 3 (or all available) ECGs. These average values were used in all change from baseline calculations. |
| Primary | Time-Matched Change From Baseline in QTc, Placebo-Adjusted and Corrected for Heart Rate Based on QTcF Using ΔΔQTcF: Comparison Between Moxifloxacin and Placebo (Assay Sensitivity Analysis) | Baseline to 60 mins and 2, 3, and 4 hours post-dose for each of the 3 treatment period dosing visits. | For the assay sensitivity analysis in support of the primary central tendency analysis, the changes from baseline (ΔQTcF) were compared between moxifloxacin (positive control) and placebo (ΔΔQTcF). Baseline was defined as the mean of the 9 ECGs (3 sets of triplicate ECGs) recorded at baseline (P1V1). In case any of the 9 ECGs were missing, the baseline was defined as the mean of the available baseline values. The post-dose ECGs were evaluated at 60 mins and 2, 3 and 4 hours post-dose for each of the 3 treatment period dosing visits in the Randomized Crossover Assessment Phase. For each of the time points, an average value was calculated based on the 3 (or all available) ECGs. These average values were used in all change from baseline calculations. |
| Secondary | Cmax of Apomorphine and Apomorphine Sulfate (Metabolite) Following the Administration of APL-130277 | Blood samples for PK assessments were taken prior to dosing and at 0.5, 0.75, 1, 2, and 4 hours post-dose. | The maximum observed plasma concentration (Cmax) for apomorphine and apomorphine sulfate (metabolite) was determined in patients treated with APL-130277. Pharmacokinetic (PK) parameters were derived using a non-compartmental analysis method. Bioanalysis of apomorphine and apomorphine-sulfate plasma concentration were measured using a validated liquid chromatography-tandem mass spectrometry (LC/MS-MS) method. The calibration range was 0.0200 nanograms per milliliter (ng/mL) to 20.0 ng/mL apomorphine and 10.0 to 1000 ng/mL apomorphine sulfate (metabolite). PK assessments were performed at each period of the Randomized Crossover Assessment Phase (at P1V1, P2V2 and P3V3) and results are presented for each of the APL-130277 doses administered (as determined for each patient during the Dose Titration Phase). |
| Secondary | Tmax of Apomorphine and Apomorphine Sulfate (Metabolite) Following the Administration of APL-130277 | Blood samples for PK assessments were taken prior to dosing and at 0.5, 0.75, 1, 2, and 4 hours post-dose. | The time of maximum observed plasma concentration (Tmax) for apomorphine and apomorphine sulfate (metabolite) was determined in patients treated with APL-130277. PK parameters were derived using a non-compartmental analysis method. Bioanalysis of apomorphine and apomorphine-sulfate plasma concentration were measured using a validated LC/MS-MS method. The calibration range was 0.0200 ng/mL to 20.0 ng/mL apomorphine and 10.0 to 1000 ng/mL apomorphine sulfate. PK assessments were performed at each period of the Randomized Crossover Assessment Phase (at P1V1, P2V2 and P3V3) and results are presented for each of the APL-130277 doses administered (as determined for each patient during the Dose Titration Phase). |
| Secondary | AUClast of Apomorphine and Apomorphine Sulfate (Metabolite) Following the Administration of APL-130277 | Blood samples for PK assessments were taken prior to dosing and at 0.5, 0.75, 1, 2, and 4 hours post-dose. | The area under the concentration-time curve from time of dosing to the last measurable point (AUClast) for apomorphine and apomorphine sulfate (metabolite) was determined in patients treated with APL-130277. PK parameters were derived using a non-compartmental analysis method. Bioanalysis of apomorphine and apomorphine-sulfate plasma concentration were measured using a validated LC/MS-MS method. The calibration range was 0.0200 ng/mL to 20.0 ng/mL apomorphine and 10.0 to 1000 ng/mL apomorphine sulfate. PK assessments were performed at each period of the Randomized Crossover Assessment Phase (at P1V1, P2V2 and P3V3) and results are presented for each of the APL-130277 doses administered (as determined for each patient during the Dose Titration Phase). |
| Secondary | Number of Patients With Treatment-Emergent Adverse Events (TEAEs) | From first dose of study medication up to last study visit for Randomized Crossover Assessment Phase, approximately up to 2 weeks | AE definition: any untoward medical occurrence in a clinical trial participant. Serious AE definition: an AE that is fatal, life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in permanent (persistent) disability/incapacity, is a congenital anomaly/birth defect or is an important medical event. Severity of AEs were classified as: mild: causes no limitation of usual activities, moderate: causes some limitation of usual activities; or severe: prevents or severely limits usual activities. The investigator assessed AEs for relatedness to study medication. TEAEs were defined as all AEs that started on or after the first dose of study medication (APL-130277, moxifloxacin or placebo). Results are presented for TEAEs during the Randomized Crossover Assessment Phase. |
| Secondary | ECG Assessments: Mean Change From Baseline to Post-Baseline Value for QTcB Interval During Randomized Crossover Assessment Phase | Baseline and at 15, 30, 45, 60 minutes and 2, 3, and 4 hours post-dose for each of the 3 treatment period dosing visits during the Randomized Crossover Assessment Phase. | QTcB was defined as QT interval corrected with Bazett's method. QT was defined as time between start of Q wave and end of T wave. QTcB was determined during continuous 12-lead ECG (Holter) monitoring at each of the 3 treatment period dosing visits at pre-specified timepoints post-dose. Baseline was defined as the mean of the 9 ECGs (3 sets of triplicate ECGs) recorded at baseline (pre-dose P1V1). In case any of the 9 ECGs were missing, the baseline was defined as the mean of the available baseline values. The post-dose ECGs were evaluated at 15, 30, 45 and 60 mins and 2, 3 and 4 hours post-dose at each of the 3 treatment period dosing visits during the Randomized Crossover Assessment Phase. For each of the time points, an average value was calculated based on the 3 (or all available) ECGs. Results are presented for the mean change from baseline at each pre-specified post-dose timepoint. |
| Secondary | Mean Change From Pre-Dose to Post-Baseline Value in the Movement Disorders Society Unified Parkinson's Disease Rating Scale Part III Motor Examination (MDS-UPDRS Part III) Score During the Dose Titration Phase | Baseline (pre-dose) and at 30, 60 and 90 minutes after dosing during the Dose Titration Phase. | The Motor Function section (Part III) of the MDS-UPDRS was administered by the Investigator, and included 33 scores based on 18-items, each anchored with 5 responses: 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range was from 0 to 132, with a lower score indicating better motor function and a higher score indicating more severe motor symptoms. The least squares mean change in the MDS-UPDRS Part III score from pre-dose to 30, 60 and 90 minutes post-dose during the Dose Titration Phase at the highest tolerated APL-130277 dose level (indicated as Day 2) and the lowest APL-130277 dose resulting in a full 'ON' (indicated as Day 1) are presented. |
| Secondary | Median Time to 'ON' During the Dose Titration Phase | Time of dosing up to 90 minutes post-dose during the Dose Titration Phase. | The time to 'ON' was calculated as minutes from the time when the patient received APL-130277 until the time the patient turned fully 'ON', as assessed by the Investigator. Data was censored at 90 minutes. The median time to a full 'ON' response during the Dose Titration Phase following the highest tolerated APL-130277 dose level (indicated as Day 2) and the lowest APL-130277 dose resulting in a full 'ON' (indicated as Day 1) are presented. The median time to 'ON' on Day 1 and Day 2 was calculated using the Kaplan-Meier method. |
| Secondary | Median Duration of 'ON' During the Dose Titration Phase | Time of dosing up to 90 minutes post-dose during the Dose Titration Phase. | The duration of 'ON' was calculated as minutes from the time when the patient turned fully 'ON' until the time when the patient turned 'OFF', as assessed by the Investigator. If the patient did not turn fully 'ON' within 90 minutes the duration of 'ON' was defined as zero minutes. If the patient turned fully 'ON' and did not turn 'OFF' by 90 minutes, the data was censored at 90 minutes minus the time when the patient turned fully 'ON'. The median duration of a full 'ON' response during the Dose Titration Phase following the highest tolerated APL-130277 dose level (indicated as Day 2) and the lowest APL-130277 dose resulting in a full 'ON' (indicated as Day 1) are presented. The median duration of 'ON' on Day 1 and Day 2 was calculated using the Kaplan-Meier method. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time-Matched Change From Baseline in QTc, Placebo-Adjusted and Corrected for Heart Rate Based on the Fridericia Correction Method (QTcF) Using Delta Delta Method (ΔΔQTcF): Comparison Between APL-130277 and Placebo (Central Tendency Analysis) | Baseline to 15, 30, 45, 60 mins and 2, 3, and 4 hours post-dose for each of the 3 treatment period dosing visits. | The ECG Population included all randomized patients who had evaluable baseline 12-lead ECG (Holter) data at P1V1 and at least one evaluable post-dose 12-lead ECG (Holter) assessment during the Randomized Crossover Assessment Phase.~Please Note: The pre-specified primary comparison was between APL-130277 and Placebo. | msec | LEAST_SQUARES_MEAN |
| SECONDARY | Cmax of Apomorphine and Apomorphine Sulfate (Metabolite) Following the Administration of APL-130277 | Blood samples for PK assessments were taken prior to dosing and at 0.5, 0.75, 1, 2, and 4 hours post-dose. | The PK population included all patients with at least one PK evaluation. Only patients with data available for analysis are presented. | ng/mL | MEAN |
| SECONDARY | Tmax of Apomorphine and Apomorphine Sulfate (Metabolite) Following the Administration of APL-130277 | Blood samples for PK assessments were taken prior to dosing and at 0.5, 0.75, 1, 2, and 4 hours post-dose. | The PK population included all patients with at least one PK evaluation. Only patients with data available for analysis are presented. | hours | MEDIAN |
| SECONDARY | AUClast of Apomorphine and Apomorphine Sulfate (Metabolite) Following the Administration of APL-130277 | Blood samples for PK assessments were taken prior to dosing and at 0.5, 0.75, 1, 2, and 4 hours post-dose. | The PK population included all patients with at least one PK evaluation. Only patients with data available for analysis are presented. | h*ng/mL | MEAN |
| SECONDARY | Number of Patients With Treatment-Emergent Adverse Events (TEAEs) | From first dose of study medication up to last study visit for Randomized Crossover Assessment Phase, approximately up to 2 weeks | The Crossover Phase Safety Population consisted of all patients who were randomized and received at least one post-randomization dose of study medication (APL-130277, moxifloxacin or placebo) during the Randomized Crossover Assessment Phase. | participants | NUMBER |
| SECONDARY | ECG Assessments: Mean Change From Baseline to Post-Baseline Value for QTcB Interval During Randomized Crossover Assessment Phase | Baseline and at 15, 30, 45, 60 minutes and 2, 3, and 4 hours post-dose for each of the 3 treatment period dosing visits during the Randomized Crossover Assessment Phase. | The ECG Population included all randomized patients who had evaluable baseline 12-lead ECG (Holter) data at P1V1 and at least one evaluable post-dose 12-lead ECG (Holter) assessment during the Randomized Crossover Assessment Phase. | msec | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Pre-Dose to Post-Baseline Value in the Movement Disorders Society Unified Parkinson's Disease Rating Scale Part III Motor Examination (MDS-UPDRS Part III) Score During the Dose Titration Phase | Baseline (pre-dose) and at 30, 60 and 90 minutes after dosing during the Dose Titration Phase. | The Efficacy Population included all patients who had efficacy assessments at the lowest dose level resulting in a full 'ON' and at a higher dose level during the Dose Titration Phase. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Median Time to 'ON' During the Dose Titration Phase | Time of dosing up to 90 minutes post-dose during the Dose Titration Phase. | The Efficacy Population included all patients who had efficacy assessments at the lowest dose level resulting in a full 'ON' and at a higher dose level during the Dose Titration Phase. | minutes | MEDIAN |
| SECONDARY | Median Duration of 'ON' During the Dose Titration Phase | Time of dosing up to 90 minutes post-dose during the Dose Titration Phase. | The Efficacy Population included all patients who had efficacy assessments at the lowest dose level resulting in a full 'ON' and at a higher dose level during the Dose Titration Phase. | minutess | MEDIAN |
| PRIMARY | Time-Matched Change From Baseline in QTc, Placebo-Adjusted and Corrected for Heart Rate Based on QTcF Using ΔΔQTcF: Comparison Between Moxifloxacin and Placebo (Assay Sensitivity Analysis) | Baseline to 60 mins and 2, 3, and 4 hours post-dose for each of the 3 treatment period dosing visits. | The ECG Population included all randomized patients who had evaluable baseline 12-lead ECG (Holter) data at P1V1 and at least one evaluable post-dose 12-lead ECG (Holter) assessment during the Randomized Crossover Assessment Phase.~Please Note: The pre-specified primary comparison was between APL-130277 and Placebo. | msec | LEAST_SQUARES_MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group188
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Time-Matched Change From Baseline in QTc, Placebo-Adjusted and Corrected for Heart Rate Based on the Fridericia Correction Method (QTcF) Using Delta Delta Method (ΔΔQTcF): Comparison Between APL-130277 and Placebo (Central Tendency Analysis) | APL-130277 (Cross-over) | 15 mins post-dose | 0.2 | Standard Error 1.98 | msec |
Time-Matched Change From Baseline in QTc, Placebo-Adjusted and Corrected for Heart Rate Based on the Fridericia Correction Method (QTcF) Using Delta Delta Method (ΔΔQTcF): Comparison Between APL-130277 and Placebo (Central Tendency Analysis) | Placebo (Cross-over) | 15 mins post-dose | -3.7 | Standard Error 1.97 | msec |
Time-Matched Change From Baseline in QTc, Placebo-Adjusted and Corrected for Heart Rate Based on the Fridericia Correction Method (QTcF) Using Delta Delta Method (ΔΔQTcF): Comparison Between APL-130277 and Placebo (Central Tendency Analysis) | APL-130277 (Cross-over) | 30 mins post-dose | 0.3 | Standard Error 1.98 | msec |
Time-Matched Change From Baseline in QTc, Placebo-Adjusted and Corrected for Heart Rate Based on the Fridericia Correction Method (QTcF) Using Delta Delta Method (ΔΔQTcF): Comparison Between APL-130277 and Placebo (Central Tendency Analysis) | Placebo (Cross-over) | 30 mins post-dose | -2.7 | Standard Error 1.97 | msec |
Time-Matched Change From Baseline in QTc, Placebo-Adjusted and Corrected for Heart Rate Based on the Fridericia Correction Method (QTcF) Using Delta Delta Method (ΔΔQTcF): Comparison Between APL-130277 and Placebo (Central Tendency Analysis) | APL-130277 (Cross-over) | 45 mins post-dose | 0.0 | Standard Error 1.98 | msec |
Time-Matched Change From Baseline in QTc, Placebo-Adjusted and Corrected for Heart Rate Based on the Fridericia Correction Method (QTcF) Using Delta Delta Method (ΔΔQTcF): Comparison Between APL-130277 and Placebo (Central Tendency Analysis) | Placebo (Cross-over) | 45 mins post-dose | -3.7 | Standard Error 1.97 | msec |
Time-Matched Change From Baseline in QTc, Placebo-Adjusted and Corrected for Heart Rate Based on the Fridericia Correction Method (QTcF) Using Delta Delta Method (ΔΔQTcF): Comparison Between APL-130277 and Placebo (Central Tendency Analysis) | APL-130277 (Cross-over) | 60 mins post-dose | 2.7 | Standard Error 1.98 | msec |
Time-Matched Change From Baseline in QTc, Placebo-Adjusted and Corrected for Heart Rate Based on the Fridericia Correction Method (QTcF) Using Delta Delta Method (ΔΔQTcF): Comparison Between APL-130277 and Placebo (Central Tendency Analysis) | Placebo (Cross-over) | 60 mins post-dose | -3.5 | Standard Error 1.97 | msec |
Time-Matched Change From Baseline in QTc, Placebo-Adjusted and Corrected for Heart Rate Based on the Fridericia Correction Method (QTcF) Using Delta Delta Method (ΔΔQTcF): Comparison Between APL-130277 and Placebo (Central Tendency Analysis) | APL-130277 (Cross-over) | 2 hours post-dose | 1.8 | Standard Error 1.98 | msec |
Time-Matched Change From Baseline in QTc, Placebo-Adjusted and Corrected for Heart Rate Based on the Fridericia Correction Method (QTcF) Using Delta Delta Method (ΔΔQTcF): Comparison Between APL-130277 and Placebo (Central Tendency Analysis) | Placebo (Cross-over) | 2 hours post-dose | -3.0 | Standard Error 1.97 | msec |
1 to 10 of 188Source ClinicalTrials.gov
See all 188 results by groupParticipant flow147
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Titration Period | STARTED | APL-130277, Then Placebo, Then Moxifloxacin | 7 | |
| Titration Period | STARTED | Placebo, Then Moxifloxacin, Then APL-130277 | 7 | |
| Titration Period | STARTED | Moxifloxacin, Then APL-130277, Then Placebo | 7 | |
| Titration Period | STARTED | Moxifloxacin, Then Placebo, Then APL-130277 | 6 | |
| Titration Period | STARTED | APL-130277, Then Moxifloxacin, Then Placebo | 7 | |
| Titration Period | STARTED | Placebo, Then APL-130277, Then Moxifloxacin | 7 | |
| Titration Period | STARTED | Sequence Not Assigned | 7 | |
| Titration Period | COMPLETED | APL-130277, Then Placebo, Then Moxifloxacin | 7 | |
| Titration Period | COMPLETED | Placebo, Then Moxifloxacin, Then APL-130277 | 7 | |
| Titration Period | COMPLETED | Moxifloxacin, Then APL-130277, Then Placebo | 7 |
1 to 10 of 147Source ClinicalTrials.gov
See all 147 participant flowAdverse events144
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bundle branch block left | Cardiac disorders | APL-130277 (Titration) | 0 | 48 | 0 |
| other | Bundle branch block left | Cardiac disorders | APL-130277 (Cross-over) | 1 | 40 | 1 |
| other | Bundle branch block left | Cardiac disorders | Placebo (Crossover) | 0 | 40 | 0 |
| other | Bundle branch block left | Cardiac disorders | Moxifloxacin (Crossover) | 0 | 40 | 0 |
| other | Nodal arrhythmia | Cardiac disorders | APL-130277 (Titration) | 0 | 48 | 0 |
| other | Nodal arrhythmia | Cardiac disorders | APL-130277 (Cross-over) | 1 | 40 | 1 |
| other | Nodal arrhythmia | Cardiac disorders | Placebo (Crossover) | 0 | 40 | 0 |
| other | Nodal arrhythmia | Cardiac disorders | Moxifloxacin (Crossover) | 0 | 40 | 0 |
| other | Vertigo | Ear and labyrinth disorders | APL-130277 (Titration) | 2 | 48 | 2 |
| other | Vertigo | Ear and labyrinth disorders | APL-130277 (Cross-over) | 0 | 40 | 0 |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | APL-130277 (Titration) | 0 | 48 |
| Total, all-cause mortality | APL-130277 (Cross-over) | 0 | 40 |
| Total, all-cause mortality | Placebo (Crossover) | 0 | 40 |
| Total, all-cause mortality | Moxifloxacin (Crossover) | 0 | 40 |
| Total, other adverse events | APL-130277 (Titration) | 41 | 48 |
| Total, other adverse events | APL-130277 (Cross-over) | 13 | 40 |
| Total, other adverse events | Placebo (Crossover) | 6 | 40 |
| Total, other adverse events | Moxifloxacin (Crossover) | 4 | 40 |
| Total, serious adverse events | APL-130277 (Titration) | 0 | 48 |
| Total, serious adverse events | APL-130277 (Cross-over) | 0 | 40 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35899977 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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