Trial · NCT00923091
Parallel-Group Comparison of Olmesartan (OLM), Amlodipine (AML) and Hydrochlorothiazid (HCTZ) in Hypertension
NCT00923091, Phase 3, Completed, Daiichi Sankyo; results first posted 2012-04-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Parallel-Group Comparison of Olmesartan (OLM), Amlodipine (AML) and Hydrochlorothiazid (HCTZ) in Hypertension. Trials, record NCT00923091. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00923091
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Parallel-Group Comparison of Olmesartan (OLM), Amlodipine (AML) and Hydrochlorothiazid (HCTZ) in Hypertension
- NCT number
- NCT00923091
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,689 participants, actual
- Lead sponsor
- Daiichi Sankyo
- Conditions
- Essential Hypertension
- Interventions
olmesartan medoxomil + amlodipine + hydroclororthiazide + placebo, Olmesartan medoxomil + amlodipine + hydrochlorothiazide + placebo, olmesartan medoxomil + amlodipine + hydroclororthiazide, olmesartan medoxomil + amlodipine + hydroclororthiazide, olmesartan medoxomil + amlodipine + hydroclororthiazide, olmesartan medoxomil + amlodipine, olmesartan medoxomil + amlodipine, olmesartan medoxomil + amlodipine
- First posted
- 2009-06-18
- Last updated
- 2019-01-10
- Results first posted
- 2012-04-06
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Seated Diastolic Blood Pressure (SeDBP). | Baseline to week 10 | Baseline blood pressure was defined as the average values obtained at the randomization visit and at the visit prior to randomization |
| Secondary | Change in Seated Systolic Blood Pressure (SeDBP). | Baseline to week 10 | |
| Secondary | Number of Subjects Reaching Blood Pressure Goal at Week 10 | baseline to week 10 | Blood pressure treatment goal was defined as blood pressure \<140/90 mmHg or \<130/80 mmHg for subjects with diabetes, chronic renal disease, or chronic cardiovascular disease. |
| Secondary | Change in Seated Diastolic Blood Pressure From Week 18 to Week 22 | Week 18 to week 22 | |
| Secondary | Change in Seated Systolic Blood Pressure From Week 18 to Week 22 | Week 18 to week 22 | |
| Secondary | Number of Subjects Reaching Blood Pressure Goal From Week 18 to Week 22 | Week 18 to week 22 | Blood pressure treatment goal was defined as blood pressure \<140/90 mmHg or \<130/80 mmHg for subjects with diabetes, chronic renal disease, or chronic cardiovascular disease. |
| Secondary | Change in Seated Diastolic Blood Pressure From Week 22 to Week 26 | Week 22 to week 26 | |
| Secondary | Change in Seated Systolic Blood Pressure From Week 22 to Week 26 | Week 22 to week 26 | |
| Secondary | Number of Subjects Reaching Blood Pressure Goal at Week 26 | Week 22 to week 26 | Blood pressure treatment goal was defined as blood pressure \<140/90 mmHg or \<130/80 mmHg for subjects with diabetes, chronic renal disease, or chronic cardiovascular disease. |
| Secondary | Change in Seated Systolic Blood Pressure (SeDBP) During Open-Label Period VI (Titration Effect From OM/AML/HCTZ 40/5/25 to 40/10/25. | Week 26 to week 54 |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Seated Diastolic Blood Pressure (SeDBP). | Baseline to week 10 | The full analysis set includes 2679 randomized patients who received at least 1 dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period I-II | mm HG | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Seated Systolic Blood Pressure (SeDBP). | Baseline to week 10 | The full analysis set includes 2679 randomized patients who received at least 1 dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period I-II | mm Hg | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Subjects Reaching Blood Pressure Goal at Week 10 | baseline to week 10 | The full analysis set includes 2679 randomized patients who received at least 1 dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period I-II | Participants | NUMBER |
| SECONDARY | Change in Seated Diastolic Blood Pressure From Week 18 to Week 22 | Week 18 to week 22 | The Full Analysis Set 2=681 randomized participants who received at least 1 dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period IV | mm Hg | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Seated Systolic Blood Pressure From Week 18 to Week 22 | Week 18 to week 22 | The Full Analysis Set 2=681 randomized participants who received at least 1 dose of double-blind medication and who provided at least one blood pressure measurement in Period IV | mm Hg | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Subjects Reaching Blood Pressure Goal From Week 18 to Week 22 | Week 18 to week 22 | The Full Analysis Set 2=681 randomized participants who received at least 1 dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period IV | Participants | NUMBER |
| SECONDARY | Change in Seated Diastolic Blood Pressure From Week 22 to Week 26 | Week 22 to week 26 | The Full Analysis Set 3=312 randomized participants who received at least one dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period V. | mm Hg | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Seated Systolic Blood Pressure From Week 22 to Week 26 | Week 22 to week 26 | The Full Analysis Set 3=312 randomized participants who received at least one dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period V. | mm Hg | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Subjects Reaching Blood Pressure Goal at Week 26 | Week 22 to week 26 | The Full Analysis Set 3=312 randomized participants who received at least one dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period V | Participants | NUMBER |
| SECONDARY | Change in Seated Systolic Blood Pressure (SeDBP) During Open-Label Period VI (Titration Effect From OM/AML/HCTZ 40/5/25 to 40/10/25. | Week 26 to week 54 | The number of subjects up titrated who had blood pressure values at both time points. | mm Hg | MEAN |
Source ClinicalTrials.gov
Results by group37
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Seated Diastolic Blood Pressure (SeDBP). | Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg | -22.5 | Standard Error 0.48 | mm HG | |
| Change in Seated Diastolic Blood Pressure (SeDBP). | Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg | -22.5 | Standard Error 0.48 | mm HG | |
| Change in Seated Diastolic Blood Pressure (SeDBP). | Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg | -23.0 | Standard Error 0.48 | mm HG | |
| Change in Seated Diastolic Blood Pressure (SeDBP). | Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg | -23.9 | Standard Error 0.47 | mm HG | |
| Change in Seated Diastolic Blood Pressure (SeDBP). | Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg | -23.8 | Standard Error 0.48 | mm HG | |
| Change in Seated Diastolic Blood Pressure (SeDBP). | Olmesartan/Amlodipine 20mg/5mg | -20.5 | Standard Error 0.47 | mm HG | |
| Change in Seated Diastolic Blood Pressure (SeDBP). | Olmesartan/Amlodipine 40mg/5mg | -21.2 | Standard Error 0.48 | mm HG | |
| Change in Seated Diastolic Blood Pressure (SeDBP). | Olmesartan/Amlodipine 40mg/10mg | -22.1 | Standard Error 0.48 | mm HG | |
| Change in Seated Systolic Blood Pressure (SeDBP). | Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg | -33.2 | Standard Error 0.72 | mm Hg | |
| Change in Seated Systolic Blood Pressure (SeDBP). | Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg | -33.7 | Standard Error 0.72 | mm Hg |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 results by groupParticipant flow195
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| PeriodI-II (Randomized, Double-Blind) | STARTED | Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5mg | 335 | |
| PeriodI-II (Randomized, Double-Blind) | STARTED | Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg | 336 | |
| PeriodI-II (Randomized, Double-Blind) | STARTED | Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg | 336 | |
| PeriodI-II (Randomized, Double-Blind) | STARTED | Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg | 336 | |
| PeriodI-II (Randomized, Double-Blind) | STARTED | Olmesartan/Amlodipine/Hydrochlorothiazide(HCT) 40mg/10mg/25mg | 336 | |
| PeriodI-II (Randomized, Double-Blind) | STARTED | Olmesartan(OM)20mg/Amlodipine (AML)5mg | 337 | |
| PeriodI-II (Randomized, Double-Blind) | STARTED | Olmesartan/Amlodipine 40mg/5mg | 337 | |
| PeriodI-II (Randomized, Double-Blind) | STARTED | Olmesartan/Amlodipine 40mg/10mg | 336 | |
| PeriodI-II (Randomized, Double-Blind) | STARTED | OM/AML/HCT 40/5/12.5mg Responder Continued on 40/5/12.5 mg | 0 | |
| PeriodI-II (Randomized, Double-Blind) | STARTED | OM/AML/HCT 40/5/12.5mg Non Responder Randomized to 40/5/12.5mg | 0 |
1 to 10 of 195Source ClinicalTrials.gov
See all 195 participant flowAdverse events640
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 | Oedema peripheral | General disorders | Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg | 0 | 329 | |
| other | Oedema peripheral | General disorders | Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg | 15 | 334 | |
| other | Oedema peripheral | General disorders | Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg | 0 | 331 | |
| other | Oedema peripheral | General disorders | Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg | 26 | 329 | |
| other | Oedema peripheral | General disorders | Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg | 27 | 332 | |
| other | Oedema peripheral | General disorders | Olmesartan/Amlodipine 20mg/5mg | 11 | 333 | |
| other | Oedema peripheral | General disorders | Olmesartan/Amlodipine 40mg/5mg | 16 | 332 | |
| other | Oedema peripheral | General disorders | Olmesartan/Amlodipine 40mg/10mg | 30 | 325 | |
| other | Headache | Nervous system disorders | Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg | 12 | 329 | |
| other | Headache | Nervous system disorders | Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg | 16 | 334 |
1 to 10 of 640Source ClinicalTrials.gov
See all 640 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg | ||
| Total, all-cause mortality | Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg | ||
| Total, all-cause mortality | Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg | ||
| Total, all-cause mortality | Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg | ||
| Total, all-cause mortality | Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg | ||
| Total, all-cause mortality | Olmesartan/Amlodipine 20mg/5mg | ||
| Total, all-cause mortality | Olmesartan/Amlodipine 40mg/5mg | ||
| Total, all-cause mortality | Olmesartan/Amlodipine 40mg/10mg | ||
| Total, other adverse events | Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg | 12 | 329 |
| Total, other adverse events | Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg | 44 | 334 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers3
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg vs Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg: Number of Subjects Reaching Blood Pressure Goal From Week 18 to Week 22 | Trial comparisons |
| OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/12.5 vs OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/25: Number of Subjects Reaching Blood Pressure Goal at Week 26 | 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/NCT00923091
GET https://conductscience.org/api/trials/v1/NCT00923091/results?page=2