Trial · NCT01215227
An Active-Controlled Extension Study to NCT01155466 [P04938] and NCT01227265 [P07037] (P06153)
NCT01215227, Phase 3, Terminated, Merck Sharp & Dohme LLC; results first posted 2016-12-12
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. An Active-Controlled Extension Study to NCT01155466 [P04938] and NCT01227265 [P07037] (P06153). Trials, record NCT01215227. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01215227
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Active-Controlled Extension Study to NCT01155466 [P04938] and NCT01227265 [P07037] (P06153)
- NCT number
- NCT01215227
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 839 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Parkinson Disease, Idiopathic Parkinson Disease
- Interventions
- Preladenant, Rasagiline, Placebo to preladenant, Placebo to rasagiline
- First posted
- 2010-10-06
- Last updated
- 2018-11-06
- Other registries' IDs
- eudract:2009-015162-57
- Results first posted
- 2016-12-12
- Limitations and caveats
- This study was terminated early due to the lack of efficacy of preladenant in the parent studies NCT1155466 and NCT01227265.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Systolic Blood Pressure ≥180 mmHg | Up to 42 weeks | The percentage of participants with Systolic Blood Pressure ≥180 mm Hg was reported. On Day 1 and Early Termination, blood pressure was measured as follows: Participant lay supine for 5 minutes, then had blood pressure taken; then stood for 3 minutes and had blood pressure taken; then rested for 10 minutes, at which time the process was repeated twice (ie, three rounds total). For all other blood pressure measurements, the procedure needed only to be done once (ie, one round). |
| Primary | Percentage of Participants With Diastolic Blood Pressure ≥105 mmHg | Up to 42 weeks | The percentage of participants with Diastolic Blood Pressure ≥105 mmHg was reported. On Day 1 and Early Termination, blood pressure was measured as follows: Participant lay supine for 5 minutes, then had blood pressure taken; then stood for 3 minutes and had blood pressure taken; then rested for 10 minutes, at which time the process was repeated twice (ie, three rounds total). For all other blood pressure measurements, the procedure needed only to be done once (ie, one round). |
| Primary | Percentage of Participants With Alanine Aminotransferase (ALT) ≥3 Times Upper Limit of Normal and ≥10% Increase From Baseline | Up to 42 weeks | The number of participants with ALT ≥3 times the upper limit of normal and a ≥10% increase was reported. Laboratory safety blood work was collected from participants at Week 4, Week 6, and Week 8 visits. |
| Primary | Percentage of Participants With Aspartate Aminotransferase (AST) ≥3 Times Upper Limit of Normal and ≥10% Increase From Baseline | Up to 42 weeks | The number of participants with AST ≥3 times the upper limit of normal and a ≥10% increase was reported. Laboratory safety blood work was collected from participants at Week 4, Week 6, and Week 8 visits. |
| Primary | Percentage of Participants With Suicidality | Up to 42 weeks | The number of participants with suicidality using the Columbia - Suicide Severity Rating Scale (C-SSRS) was reported. The C-SSR was used in this study only for the purpose of safety monitoring by measuring the incidence of different types of suicidality categories during treatment. The assessment was done by the nature of the responses, not by a numbered scale. Participants who reported at least one occurrence of suicidal behavior or suicidal ideation were counted as having experienced suicidality. Suicidal behavior included suicide attempt, aborted attempt, interrupted attempt, or preparatory behavior. Suicidal ideation included a wish to die or active suicidal thought with or without method, intent or plan. |
| Primary | Percentage Change From Baseline in Total Epworth Sleepiness Scale (ESS) Score at Week 40 | Baseline and Week 40 | The ESS is a self-administered questionnaire providing a measure of a person's general level of daytime sleepiness, or their average sleep propensity in daily life. The scale consists of 8 situations in which the participant rates their tendency to become sleepy on a scale of 0=no chance of dozing to 3=high chance of dozing. The overall score is the sum of the scores for the 8 situations for a minimum of 0 and a maximum of 24 with a higher score indicating greater sleepiness. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Systolic Blood Pressure ≥180 mmHg | Up to 42 weeks | All Participants as Treated (APaT) population, which consisted of all participants who received at least one dose of study drug. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Diastolic Blood Pressure ≥105 mmHg | Up to 42 weeks | APaT population, which consisted of all participants who received at least one dose of study drug. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Alanine Aminotransferase (ALT) ≥3 Times Upper Limit of Normal and ≥10% Increase From Baseline | Up to 42 weeks | APaT population, which consisted of all participants who received at least one dose of study drug. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Aspartate Aminotransferase (AST) ≥3 Times Upper Limit of Normal and ≥10% Increase From Baseline | Up to 42 weeks | APaT population, which consisted of all participants who received at least one dose of study drug. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Suicidality | Up to 42 weeks | APaT population, which consisted of all participants who received at least one dose of study drug. | Percentage of participants | NUMBER |
| PRIMARY | Percentage Change From Baseline in Total Epworth Sleepiness Scale (ESS) Score at Week 40 | Baseline and Week 40 | Participants in the Full Analysis Set (FAS) population (all randomized participants who received at least one dose of study drug) that had a baseline value and data at Week 40 for Total ESS Score | Percentage change | MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Systolic Blood Pressure ≥180 mmHg | Preladenant 2 mg | 1.4 | Percentage of participants | ||
| Percentage of Participants With Systolic Blood Pressure ≥180 mmHg | Preladenant 5 mg | 0.0 | Percentage of participants | ||
| Percentage of Participants With Systolic Blood Pressure ≥180 mmHg | Preladenant 5 mg (on Placebo in Parent Study) | 0.9 | Percentage of participants | ||
| Percentage of Participants With Systolic Blood Pressure ≥180 mmHg | Preladenant 10 mg | 1.0 | Percentage of participants | ||
| Percentage of Participants With Systolic Blood Pressure ≥180 mmHg | Rasagiline 1 mg | 0.0 | Percentage of participants | ||
| Percentage of Participants With Systolic Blood Pressure ≥180 mmHg | Rasagiline 1 mg (on Placebo in Parent Study) | 0.9 | Percentage of participants | ||
| Percentage of Participants With Diastolic Blood Pressure ≥105 mmHg | Preladenant 2 mg | 5.0 | Percentage of participants | ||
| Percentage of Participants With Diastolic Blood Pressure ≥105 mmHg | Preladenant 5 mg | 4.2 | Percentage of participants | ||
| Percentage of Participants With Diastolic Blood Pressure ≥105 mmHg | Preladenant 5 mg (on Placebo in Parent Study) | 5.7 | Percentage of participants | ||
| Percentage of Participants With Diastolic Blood Pressure ≥105 mmHg | Preladenant 10 mg | 5.2 | Percentage of participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Preladenant 2 mg | 218 | |
| Overall Study | STARTED | Preladenant 5 mg | 215 | |
| Overall Study | STARTED | Preladenant 5 mg (on Placebo in Parent Study) | 107 | |
| Overall Study | STARTED | Preladenant 10 mg | 97 | |
| Overall Study | STARTED | Rasagiline 1 mg | 93 | |
| Overall Study | STARTED | Rasagiline 1 mg (on Placebo in Parent Study) | 109 | |
| Overall Study | Treated | Preladenant 2 mg | 218 | |
| Overall Study | Treated | Preladenant 5 mg | 215 | |
| Overall Study | Treated | Preladenant 5 mg (on Placebo in Parent Study) | 106 | |
| Overall Study | Treated | Preladenant 10 mg | 96 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events468
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 | CONSTIPATION | Gastrointestinal disorders | Preladenant 2 mg | 9 | 218 | 10 |
| other | CONSTIPATION | Gastrointestinal disorders | Preladenant 5 mg | 12 | 215 | 14 |
| other | CONSTIPATION | Gastrointestinal disorders | Preladenant 5 mg (on Placebo in Parent Study) | 7 | 106 | 7 |
| other | CONSTIPATION | Gastrointestinal disorders | Preladenant 10 mg | 5 | 96 | 5 |
| other | CONSTIPATION | Gastrointestinal disorders | Rasagiline 1 mg | 1 | 93 | 1 |
| other | CONSTIPATION | Gastrointestinal disorders | Rasagiline 1 mg (on Placebo in Parent Study) | 3 | 108 | 5 |
| other | NAUSEA | Gastrointestinal disorders | Preladenant 2 mg | 6 | 218 | 6 |
| other | NAUSEA | Gastrointestinal disorders | Preladenant 5 mg | 8 | 215 | 11 |
| other | NAUSEA | Gastrointestinal disorders | Preladenant 5 mg (on Placebo in Parent Study) | 3 | 106 | 3 |
| other | NAUSEA | Gastrointestinal disorders | Preladenant 10 mg | 1 | 96 | 1 |
1 to 10 of 468Source ClinicalTrials.gov
See all 468 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Preladenant 2 mg | ||
| Total, all-cause mortality | Preladenant 5 mg | ||
| Total, all-cause mortality | Preladenant 5 mg (on Placebo in Parent Study) | ||
| Total, all-cause mortality | Preladenant 10 mg | ||
| Total, all-cause mortality | Rasagiline 1 mg | ||
| Total, all-cause mortality | Rasagiline 1 mg (on Placebo in Parent Study) | ||
| Total, other adverse events | Preladenant 2 mg | 64 | 218 |
| Total, other adverse events | Preladenant 5 mg | 71 | 215 |
| Total, other adverse events | Preladenant 5 mg (on Placebo in Parent Study) | 30 | 106 |
| Total, other adverse events | Preladenant 10 mg | 35 | 96 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01215227
GET https://conductscience.org/api/trials/v1/NCT01215227/results?page=2