Phase 3
N=971
Use of the Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension
Essential Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00430508 ↗Enrolled (actual)
971
Serious AEs
—
Results posted
Jun 2009
Primary outcome: Primary: Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16 — -11.16; -9.13; -8.10; -5.66 mm Hg — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo (Drug); olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets (Drug); olmesartan medoxomil/hydrochlorothiazide tablets (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Daiichi Sankyo
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16 |
-11.16; -9.13; -8.10; -5.66 | <0.0001 sig |
| SECONDARY Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12. |
-8.74; -7.72; -6.66; -4.47 | <0.0001 sig |
| SECONDARY Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 16. |
-16.17; -13.52; -11.46; -8.85 | <0.0001 sig |
| SECONDARY Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 12. |
-13.16; -10.90; -9.65; -6.60 | <0.0001 sig |
| SECONDARY Number of Patients Achieving Target Blood Pressure at Week 16 |
59; 110; 88; 68 | — |
| SECONDARY Change in Mean 24-hour Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16. |
-7.2; -5.3; -4.1; -2.0 | <0.0001 sig |
| SECONDARY Change in Mean Daytime Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16. |
-7.0; -5.5; -4.0; -1.8 | <0.0001 sig |
| SECONDARY Change in Mean Night-time Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16. |
-7.9; -4.5; -4.2; -2.3 | <0.0001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Male or female Europeans aged 18 years or older with moderate to severe hypertension (HTN)
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 (NCT00430508). 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.