Trial · NCT00430950
Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension
NCT00430950, Phase 3, Completed, Daiichi Sankyo; results first posted 2009-04-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension. Trials, record NCT00430950. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00430950
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension
- NCT number
- NCT00430950
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,011 participants, actual
- Lead sponsor
- Daiichi Sankyo
- Conditions
- Essential Hypertension
- Interventions
- olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tablets, olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg
- First posted
- 2007-02-02
- Last updated
- 2019-01-10
- Results first posted
- 2009-04-20
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Mean Trough Sitting Diastolic Blood Pressure | 8 weeks | Change in mean trough sitting diastolic Blood Pressure between OM/HCTZ 20/25 mg vs. 40/25 mg, in those patients inadequately controlled on OM 40 mg monotherapy, after eight weeks of double blind treatment, as compared to baseline. Change = Week 16 - Week 8 (baseline). |
| Secondary | Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12 | 4 weeks | Change = Week 12 - Week 8 (baseline). |
| Secondary | Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline. | 8 weeks | 4 weeks Change = Week 12 - Week 8 (baseline). 8 weeks Change = Week 16 - Week 8 (baseline). |
| Secondary | Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline. | 8 weeks | Change = Week 16 - Week 8 (baseline). |
| Secondary | Number of Participants Achieving Blood Pressure Goal. | 8 weeks |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Mean Trough Sitting Diastolic Blood Pressure | 8 weeks | The main analysis will be performed on the full analysis set last observation carried forward (LOCF). Pooling will be applied for small centres. | mm Hg | MEAN |
| SECONDARY | Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12 | 4 weeks | mm Hg | MEAN | |
| SECONDARY | Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline. | 8 weeks | mm Hg | MEAN | |
| SECONDARY | Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline. | 8 weeks | Exploratory analysis: ANCOVA was used to compare the differences in change from baseline (Visit 4, Week 8) to Week 16 (Visit 6) in daytime, nighttime and 24-hr ABPM dBP and sBP. | mm Hg | MEAN |
| SECONDARY | Number of Participants Achieving Blood Pressure Goal. | 8 weeks | participants | NUMBER |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Mean Trough Sitting Diastolic Blood Pressure | OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo | -11.16 | Standard Deviation 8.851 | mm Hg | |
| Change in Mean Trough Sitting Diastolic Blood Pressure | OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo | -10.45 | Standard Deviation 7.928 | mm Hg | |
| Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12 | OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo | -9.32 | Standard Deviation 7.820 | mm Hg | |
| Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12 | OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo | -8.83 | Standard Deviation 7.584 | mm Hg | |
| Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline. | OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo | Change from baseline (Week 8) to Week 16 in sBP | -17.41 | Standard Deviation 13.930 | mm Hg |
| Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline. | OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo | Change from baseline (Week 8) to Week 16 in sBP | -17.09 | Standard Deviation 13.126 | mm Hg |
| Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline. | OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo | Change from baseline (Week 8) to Week 12 in sBP | -14.07 | Standard Deviation 12.654 | mm Hg |
| Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline. | OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo | Change from baseline (Week 8) to Week 12 in sBP | -13.80 | Standard Deviation 12.519 | mm Hg |
| Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline. | OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo | Change from Week 8 to Wk 16 in mean 24-hr ABPM dBP | -9.2 | Standard Deviation 8.69 | mm Hg |
| Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline. | OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo | Change from Week 8 to Wk 16 in mean 24-hr ABPM dBP | -7.6 | Standard Deviation 8.03 | mm Hg |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo | 502 | |
| Overall Study | STARTED | OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo | 508 | |
| Overall Study | COMPLETED | OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo | 489 | |
| Overall Study | COMPLETED | OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo | 495 | |
| Overall Study | NOT COMPLETED | OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo | 13 | |
| Overall Study | NOT COMPLETED | OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo | 13 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22114906 | DERIVED |
Source PubMed
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 |
|---|
| OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo vs OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo: Number of Participants Achieving Blood Pressure Goal. |
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/NCT00430950
GET https://conductscience.org/api/trials/v1/NCT00430950/results?page=2