Trial · NCT01005290
A Pharmacodynamic Study to Evaluate the Effect of a Fixed Dose Combination Pill on Blood Pressure
NCT01005290, Phase 2, Terminated, Ferrer Internacional S.A.; results first posted 2012-07-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Pharmacodynamic Study to Evaluate the Effect of a Fixed Dose Combination Pill on Blood Pressure. Trials, record NCT01005290. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01005290
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Pharmacodynamic Study to Evaluate the Effect of a Fixed Dose Combination Pill on Blood Pressure
- NCT number
- NCT01005290
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 38 participants, actual
- Lead sponsor
- Ferrer Internacional S.A.
- Conditions
- Hypertension
- Interventions
- Combination pill, Ramipril
- First posted
- 2009-10-30
- Last updated
- 2012-07-26
- Results first posted
- 2012-07-26
- Limitations and caveats
- Early termination leading to small numbers of subjects analyzed
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference in the Adjusted Mean 24-h Systolic Pressure Results (Using ABPM) Between the Basal and the Final Visit of Each Treatment Period. | Days 7 and 36 of Period 1 and days 49 and 85 of Period 2 | Difference in the adjusted mean 24-h systolic pressure results using ABPM (Ambulatory Blood Pressure Monitoring)in the PP population. |
| Secondary | Difference in the Adjusted Mean 24-h Diastolic Pressure Results Between the Basal and the Final Visit of Each Treatment Period | Days 7 and 36 of Period 1 and days 49 and 85 of Period 2 | Difference in the Adjusted Mean 24-h Diastolic Pressure Results (Using ABPM) Between the Basal and the Final Visit of Each Treatment Period |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Difference in the Adjusted Mean 24-h Systolic Pressure Results (Using ABPM) Between the Basal and the Final Visit of Each Treatment Period. | Days 7 and 36 of Period 1 and days 49 and 85 of Period 2 | The PP set included all randomized subjects who received at least one dose of IMP, had a baseline primary endpoint measurement, had at least one post baseline primary endpoint measurement, and who had no major protocol deviations. The PP set served as the primary analysis set for analysis of the primary endpoint. | mm Hg | MEAN |
| SECONDARY | Difference in the Adjusted Mean 24-h Diastolic Pressure Results Between the Basal and the Final Visit of Each Treatment Period | Days 7 and 36 of Period 1 and days 49 and 85 of Period 2 | The PP set included all randomized subjects who received at least one dose of IMP, had a baseline primary endpoint measurement, had at least one post baseline primary endpoint measurement, and who had no major protocol deviations. The PP set served as the primary analysis set for analysis of the primary endpoint. | mm Hg | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Difference in the Adjusted Mean 24-h Systolic Pressure Results (Using ABPM) Between the Basal and the Final Visit of Each Treatment Period. | Combination Pill | -2.40 | Standard Deviation 8.726 | mm Hg | |
| Difference in the Adjusted Mean 24-h Systolic Pressure Results (Using ABPM) Between the Basal and the Final Visit of Each Treatment Period. | Ramipril | -4.40 | Standard Deviation 8.173 | mm Hg | |
| Difference in the Adjusted Mean 24-h Diastolic Pressure Results Between the Basal and the Final Visit of Each Treatment Period | Combination Pill | -1.85 | Standard Deviation 6.714 | mm Hg | |
| Difference in the Adjusted Mean 24-h Diastolic Pressure Results Between the Basal and the Final Visit of Each Treatment Period | Ramipril | -2.88 | Standard Deviation 5.731 | mm Hg |
Source ClinicalTrials.gov
Participant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Run-In | STARTED | Pre-randomization Run-In | 52 | |
| Run-In | STARTED | Combination Pill Then Ramipril | 0 | |
| Run-In | STARTED | Ramipril Then Combination Pill | 0 | |
| Run-In | COMPLETED | Pre-randomization Run-In | 38 | |
| Run-In | COMPLETED | Combination Pill Then Ramipril | 0 | |
| Run-In | COMPLETED | Ramipril Then Combination Pill | 0 | |
| Run-In | NOT COMPLETED | Pre-randomization Run-In | 14 | |
| Run-In | NOT COMPLETED | Combination Pill Then Ramipril | 0 | |
| Run-In | NOT COMPLETED | Ramipril Then Combination Pill | 0 | |
| Period 1 (5 Weeks) | STARTED | Pre-randomization Run-In | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events2
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 | Headache | Nervous system disorders | Combination Pill | 3 | 29 | 3 |
| other | Headache | Nervous system disorders | Ramipril | 1 | 31 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Combination Pill | ||
| Total, all-cause mortality | Ramipril | ||
| Total, other adverse events | Combination Pill | 3 | 29 |
| Total, other adverse events | Ramipril | 1 | 31 |
| Total, serious adverse events | Combination Pill | 0 | 29 |
| Total, serious adverse events | Ramipril | 0 | 31 |
Source ClinicalTrials.gov
Papers0
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Combination Pill vs Ramipril: serious adverse events |
Source Trial comparisons
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/NCT01005290
GET https://conductscience.org/api/trials/v1/NCT01005290/flow?page=2