Trial · NCT00649389
Safety and Efficacy Study of a Triple Combination Therapy in Subjects With Hypertension
NCT00649389, Phase 3, Completed, Daiichi Sankyo; results first posted 2010-09-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy Study of a Triple Combination Therapy in Subjects With Hypertension. Trials, record NCT00649389. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00649389
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of a Triple Combination Therapy in Subjects With Hypertension
- NCT number
- NCT00649389
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,500 participants, actual
- Lead sponsor
- Daiichi Sankyo
- Conditions
- Hypertension
- Interventions
- Olmesartan medoxomil, Amlodipine, Hydrochlorothiazide
- First posted
- 2008-04-01
- Last updated
- 2019-01-09
- Results first posted
- 2010-09-01
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP). | baseline to 12 weeks | |
| Secondary | Percentage of Subjects Who Reached Blood Pressure Goal (<140/90 mmHg; <130/80 mmHg for Subjects With Diabetes, Chronic Renal Disease, or Chronic Cardiovascular Disease)by 12 Weeks | Baseline to 12 weeks | |
| Secondary | Change in Mean 24-hour Ambulatory Blood Pressure From Baseline to Week 12 or Early Termination | Baseline to 12 weeks or early termination | |
| Secondary | Change in Seated Systolic Blood Pressure From Baseline to Week 12 | Baseline to week 12 |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP). | baseline to 12 weeks | The full analysis set consists of subjects who received at least 1 dose of study medication and had a baseline and at least one post-dose assessment of SeDBP | mm Hg | MEAN |
| SECONDARY | Percentage of Subjects Who Reached Blood Pressure Goal (<140/90 mmHg; <130/80 mmHg for Subjects With Diabetes, Chronic Renal Disease, or Chronic Cardiovascular Disease)by 12 Weeks | Baseline to 12 weeks | The full analysis set consists of subjects who received at least 1 dose of study medication and had a baseline and at least one post-dose assessment of seated diastolic blood pressure | Percentage of subjects | NUMBER |
| SECONDARY | Change in Mean 24-hour Ambulatory Blood Pressure From Baseline to Week 12 or Early Termination | Baseline to 12 weeks or early termination | The ABPM Analysis Set included 440 subjects who provided consent to participate in the ABPM sub-study and who were to provide ABPM measurements prior to and after randomization. Those analyzed is the number who had values at both baseline and 12 weeks or early termination | mm Hg | MEAN |
| SECONDARY | Change in Seated Systolic Blood Pressure From Baseline to Week 12 | Baseline to week 12 | mm Hg | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP). | OM40/AML10 | -17.8 | Standard Deviation 9.47 | mm Hg | |
| Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP). | OM40/HCTZ25 | -16.5 | Standard Deviation 10.84 | mm Hg | |
| Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP). | AML10/HCTZ25 | -14.8 | Standard Deviation 8.78 | mm Hg | |
| Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP). | OM40/AML10/HCTZ25 | -21.5 | Standard Deviation 10.25 | mm Hg | |
| Percentage of Subjects Who Reached Blood Pressure Goal (<140/90 mmHg; <130/80 mmHg for Subjects With Diabetes, Chronic Renal Disease, or Chronic Cardiovascular Disease)by 12 Weeks | OM40/AML10 | 46.0 | Percentage of subjects | ||
| Percentage of Subjects Who Reached Blood Pressure Goal (<140/90 mmHg; <130/80 mmHg for Subjects With Diabetes, Chronic Renal Disease, or Chronic Cardiovascular Disease)by 12 Weeks | OM40/HCTZ25 | 46.6 | Percentage of subjects | ||
| Percentage of Subjects Who Reached Blood Pressure Goal (<140/90 mmHg; <130/80 mmHg for Subjects With Diabetes, Chronic Renal Disease, or Chronic Cardiovascular Disease)by 12 Weeks | AML10/HCTZ25 | 34.9 | Percentage of subjects | ||
| Percentage of Subjects Who Reached Blood Pressure Goal (<140/90 mmHg; <130/80 mmHg for Subjects With Diabetes, Chronic Renal Disease, or Chronic Cardiovascular Disease)by 12 Weeks | OM40/AML10/HCTZ25 | 64.3 | Percentage of subjects | ||
| Change in Mean 24-hour Ambulatory Blood Pressure From Baseline to Week 12 or Early Termination | OM40/AML10 | Diastolic blood pressure | -13.9 | Standard Deviation 8.09 | mm Hg |
| Change in Mean 24-hour Ambulatory Blood Pressure From Baseline to Week 12 or Early Termination | OM40/HCTZ25 | Diastolic blood pressure | -14.5 | Standard Deviation 8.73 | mm Hg |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | OM40/AML10 | 628 | |
| Overall Study | STARTED | OM40/HCTZ25 | 637 | |
| Overall Study | STARTED | AML10/HCTZ25 | 600 | |
| Overall Study | STARTED | OM40/AML10/HCTZ25 | 627 | |
| Overall Study | COMPLETED | OM40/AML10 | 557 | |
| Overall Study | COMPLETED | OM40/HCTZ25 | 531 | |
| Overall Study | COMPLETED | AML10/HCTZ25 | 512 | |
| Overall Study | COMPLETED | OM40/AML10/HCTZ25 | 516 | |
| Overall Study | NOT COMPLETED | OM40/AML10 | 71 | |
| Overall Study | NOT COMPLETED | OM40/HCTZ25 | 106 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events212
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 | dizziness | Nervous system disorders | OM40/AML10 | 29 | 596 | |
| other | dizziness | Nervous system disorders | OM40/HCTZ25 | 58 | 580 | |
| other | dizziness | Nervous system disorders | AML10/HCTZ25 | 17 | 552 | |
| other | dizziness | Nervous system disorders | OM40/AML10/HCTZ25 | 57 | 574 | |
| other | headache | Nervous system disorders | OM40/AML10 | 42 | 596 | |
| other | headache | Nervous system disorders | OM40/HCTZ25 | 38 | 580 | |
| other | headache | Nervous system disorders | AML10/HCTZ25 | 33 | 552 | |
| other | headache | Nervous system disorders | OM40/AML10/HCTZ25 | 37 | 574 | |
| other | upper respiratory tract infection | Infections and infestations | OM40/AML10 | 26 | 596 | |
| other | upper respiratory tract infection | Infections and infestations | OM40/HCTZ25 | 18 | 580 |
1 to 10 of 212Source ClinicalTrials.gov
See all 212 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OM40/AML10 | ||
| Total, all-cause mortality | OM40/HCTZ25 | ||
| Total, all-cause mortality | AML10/HCTZ25 | ||
| Total, all-cause mortality | OM40/AML10/HCTZ25 | ||
| Total, other adverse events | OM40/AML10 | 210 | 596 |
| Total, other adverse events | OM40/HCTZ25 | 210 | 580 |
| Total, other adverse events | AML10/HCTZ25 | 212 | 552 |
| Total, other adverse events | OM40/AML10/HCTZ25 | 237 | 574 |
| Total, serious adverse events | OM40/AML10 | 9 | 596 |
| Total, serious adverse events | OM40/HCTZ25 | 7 | 580 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers4
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/NCT00649389
GET https://conductscience.org/api/trials/v1/NCT00649389/events?page=2