Phase 3
Completed N=1,010
Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension
Source: ClinicalTrials.gov NCT00430950 ↗Enrolled (actual)
1,010
Serious AEs
—
Results posted
Apr 2009
Primary outcomePrimary: Change in Mean Trough Sitting Diastolic Blood Pressure — -11.16; -10.45 mm Hg — p=0.2648
Summary
The study will evaluate the blood pressure lowering effects of two different dosages of the combination of olmesartan and hydrochlorothiazide in patients with moderate or severe high blood pressure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Trough Sitting Diastolic Blood Pressure |
-11.16; -10.45 | 0.2648 |
| SECONDARY Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12 |
-9.32; -8.83 | 0.4246 |
| SECONDARY Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline. |
-17.41; -17.09; -14.07; -13.80 | 0.7019 |
| SECONDARY Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline. |
-9.2; -7.6; -9.3; -7.7; -8.6; -7.0 | 0.0016 sig |
| SECONDARY Number of Participants Achieving Blood Pressure Goal. |
260; 255 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female Europeans aged 18 years or older with moderate to severe HTN, defined as follows (conventional BP measurements)
Exclusion Criteria
- Female patients of childbearing potential pregnant, lactating or planning to become pregnant during the trial period.
- Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the study medication, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological or oncological, neurological and psychiatric diseases.
- Patients having a history of the following within the last six months:
- myocardial infarction,
- unstable angina pectoris,
- percutaneous coronary intervention,
- severe heart failure,
- hypertensive encephalopathy, cerebrovascular accident (stroke) or
- transient ischaemic attack.
- Patients with clinically significant abnormal laboratory values at screening.
- Patients with secondary HTN.
Data sourced from ClinicalTrials.gov (NCT00430950). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.