Trial · NCT02553265
Carbidopa for the Treatment of Excessive Blood Pressure Variability
NCT02553265, Phase 2, Completed, NYU Langone Health; results first posted 2022-02-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Carbidopa for the Treatment of Excessive Blood Pressure Variability. Trials, record NCT02553265. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02553265
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Carbidopa for the Treatment of Excessive Blood Pressure Variability
- NCT number
- NCT02553265
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- NYU Langone Health
- Conditions
- Dysautonomia, Familial, Baroreflex Failure Syndrome
- Interventions
- Carbidopa Low-Dose, Placebo, Carbidopa High-Dose
- First posted
- 2015-09-17
- Last updated
- 2022-02-09
- Results first posted
- 2022-02-09
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Reported Adverse Events Related to Study Drug | Up to 90 days | Adverse events defined as: a change in a patient's baseline condition including intercurrent illnesses irrespective of the relationship to carbidopa treatment. This will be monitored primarily with phone calls at weekly intervals. In addition, patients will be asked about adverse events while at the office. Patients will also fill a daily diary with a specific prompts to note any adverse events. |
| Primary | Number of Participants With Significant Changes in Body Mass That Resulted in Discontinuation From the Study. | Up to 90 days | Body mass measured in kg |
| Primary | Number of Participants With Abnormal Electrocardiographic Interval Patterns | Up to 90 days | Clinically significant changes in the intervals of characteristic electrocardiographic patterns |
| Primary | Average Systolic Blood Pressure Variability (Daytime) | up to Week 14 | Patients with FD undergo ambulatory BP monitoring while keeping a detailed log of their activities (sleep/meal-times/medications/posture/symptoms). Variability in blood pressure overtime will be measured by the standard deviation during awake hours |
| Primary | Highest Systolic Blood Pressure | Day 1 of treatment period | Maximum blood pressure captured on 24-h ambulatory monitoring |
| Primary | Systolic Blood Pressure | up to Week 14 | SBP measured in the seated position |
| Primary | Heart Rate | up to Week 14 | Heart rate in the seated position |
| Primary | Number of Participants Who Displayed Clinical Significant Laboratory Values on CBC or Metabolic Panel | Up to 90 days | Clinically significant laboratory values include complete blood count (CMC) and metabolic panel related to treatment with carbidopa |
| Primary | Number of Participants Who Displayed Clinically Significant Values in Urine Safety Parameters | Up to 90 days | Clinically significant values on urinalysis, urine safety parameters related to treatment with carbidopa |
| Secondary | Severity of Hypotension During an Active Stand Test | up to Week 14 | Lowest blood pressure captured during 3 minutes of standing |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Reported Adverse Events Related to Study Drug | Up to 90 days | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With Significant Changes in Body Mass That Resulted in Discontinuation From the Study. | Up to 90 days | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With Abnormal Electrocardiographic Interval Patterns | Up to 90 days | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Average Systolic Blood Pressure Variability (Daytime) | up to Week 14 | mmHg | MEAN | |
| PRIMARY | Highest Systolic Blood Pressure | Day 1 of treatment period | mmHg | MEAN | |
| PRIMARY | Systolic Blood Pressure | up to Week 14 | mmHg | MEAN | |
| PRIMARY | Heart Rate | up to Week 14 | beats per minute (BPM) | MEAN | |
| PRIMARY | Number of Participants Who Displayed Clinical Significant Laboratory Values on CBC or Metabolic Panel | Up to 90 days | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants Who Displayed Clinically Significant Values in Urine Safety Parameters | Up to 90 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Severity of Hypotension During an Active Stand Test | up to Week 14 | mmHg | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group45
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Reported Adverse Events Related to Study Drug | Placebo | 0 | Participants | ||
| Number of Participants Who Reported Adverse Events Related to Study Drug | Low-Dose Carbidopa | 0 | Participants | ||
| Number of Participants Who Reported Adverse Events Related to Study Drug | High-Dose Carbidopa | 0 | Participants | ||
| Number of Participants With Significant Changes in Body Mass That Resulted in Discontinuation From the Study. | Placebo | 0 | Participants | ||
| Number of Participants With Significant Changes in Body Mass That Resulted in Discontinuation From the Study. | High-Dose Carbidopa | 0 | Participants | ||
| Number of Participants With Significant Changes in Body Mass That Resulted in Discontinuation From the Study. | Low-Dose Carbidopa | 0 | Participants | ||
| Number of Participants With Abnormal Electrocardiographic Interval Patterns | Placebo | 0 | Participants | ||
| Number of Participants With Abnormal Electrocardiographic Interval Patterns | High-Dose Carbidopa | 0 | Participants | ||
| Number of Participants With Abnormal Electrocardiographic Interval Patterns | Low-Dose Carbidopa | 0 | Participants | ||
| Average Systolic Blood Pressure Variability (Daytime) | Placebo | 22.92 | Standard Deviation 6.13 | mmHg |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Enrollment | STARTED | Low-Dose Carbidopa, Then Placebo, Then High-Dose Carbidopa | 9 | |
| Enrollment | STARTED | High-Dose Carbidopa, Then Low-Dose Carbidopa, Then Placebo | 7 | |
| Enrollment | STARTED | Placebo, Then High-Dose Carbidopa, Then Low-Dose Carbidopa | 6 | |
| Enrollment | COMPLETED | Low-Dose Carbidopa, Then Placebo, Then High-Dose Carbidopa | 9 | |
| Enrollment | COMPLETED | High-Dose Carbidopa, Then Low-Dose Carbidopa, Then Placebo | 7 | |
| Enrollment | COMPLETED | Placebo, Then High-Dose Carbidopa, Then Low-Dose Carbidopa | 5 | |
| Enrollment | NOT COMPLETED | Low-Dose Carbidopa, Then Placebo, Then High-Dose Carbidopa | 0 | |
| Enrollment | NOT COMPLETED | High-Dose Carbidopa, Then Low-Dose Carbidopa, Then Placebo | 0 | |
| Enrollment | NOT COMPLETED | Placebo, Then High-Dose Carbidopa, Then Low-Dose Carbidopa | 1 | |
| First Intervention (28 Days) | STARTED | Low-Dose Carbidopa, Then Placebo, Then High-Dose Carbidopa | 9 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events9
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 | Diarrhea | Gastrointestinal disorders | Low-Dose Carbidopa | 4 | 16 | |
| other | Diarrhea | Gastrointestinal disorders | High-Dose Carbidopa | 0 | 16 | |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 0 | 16 | |
| other | Syncope | Vascular disorders | Low-Dose Carbidopa | 0 | 16 | |
| other | Syncope | Vascular disorders | High-Dose Carbidopa | 3 | 16 | |
| other | Syncope | Vascular disorders | Placebo | 0 | 16 | |
| serious | Hospitaliztion | General disorders | Low-Dose Carbidopa | 1 | 16 | 1 |
| serious | Hospitaliztion | General disorders | High-Dose Carbidopa | 0 | 16 | |
| serious | Hospitaliztion | General disorders | Placebo | 0 | 16 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Low-Dose Carbidopa | 1 | 16 |
| Total, all-cause mortality | High-Dose Carbidopa | 0 | 16 |
| Total, all-cause mortality | Placebo | 0 | 16 |
| Total, other adverse events | Low-Dose Carbidopa | 4 | 16 |
| Total, other adverse events | High-Dose Carbidopa | 3 | 16 |
| Total, other adverse events | Placebo | 0 | 16 |
| Total, serious adverse events | Low-Dose Carbidopa | 1 | 16 |
| Total, serious adverse events | High-Dose Carbidopa | 0 | 16 |
| Total, serious adverse events | Placebo | 0 | 16 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
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/NCT02553265
GET https://conductscience.org/api/trials/v1/NCT02553265/results?page=2