Phase 4
N=694
Olmesartan and an add-on Treatment in Patients With Mild to Moderate Hypertension
Essential Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00311155 ↗Enrolled (actual)
694
Serious AEs
1.0%
Results posted
Nov 2010
Primary outcome: Primary: The Percentage of Participants Treated to Target Blood Pressure Goals Overall and for Each Treatment Step From Baseline to Completion of Treatment During Which the Goal Was Achieved. — 71.8; 12.3; 16.4; 19.2 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sankyo Pharma Gmbh
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Participants Treated to Target Blood Pressure Goals Overall and for Each Treatment Step From Baseline to Completion of Treatment During Which the Goal Was Achieved. |
71.8; 12.3; 16.4; 19.2; 14.9; 8.5 | — |
| SECONDARY Percentage of Participants Who Achieved Normalized Blood Pressure Overall and for Each Treatment From Baseline to Completion of the Treatment During Which Blood Pressure Goals Were Achieved |
84.5; 22.7; 31.1; 32.7; 23.9; 14.8 | — |
| SECONDARY Percentage of Participants Who Were Diastolic Responders Overall and for Each Treatment From Baseline to the Completion of Treatment During Which Blood Pressure Goals Were Achieved. |
93.3; 36.6; 52.4; 48.6; 33.4; 20.4 | — |
| SECONDARY Percentage of Participants Who Were Systolic Responders Overall and for Each Treatment From Baseline to the Completion of the Treatment During Which Blood Pressure Goals Were Achieved |
92.6; 34.2; 49.6; 46.6; 33.3; 20.5 | — |
| SECONDARY Mean Change in Diastolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment |
-15.73; -6.44; -10.15; -13.04; -14.03; -14.47 | — |
| SECONDARY Mean Change in Systolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment |
-29.58; -11.97; -19.55; -24.51; -27.06; -28.02 | — |
Summary
This study is to assess the safety and efficacy of an add-on treatment algorithm with olmesartan, hydrochlorothiazide and amlodipine in patients with mild to moderate hypertension.
Eligibility Criteria
Inclusion Criteria
- Male and female patients age greater than or equal to 18 years with mild to moderate hypertension.
- Pre-treated patients with normal or elevated blood pressure (BP) are eligible to participate if their pre-treatment medication can be withdrawn. At the end of the placebo run-in period sitting systolic BP greater than or equal to 140 and less than 180 mmHg and/or sitting diastolic BP greater than or equal to 90 and less than 110 mmHg at trough.
Exclusion Criteria
- Female patients of childbearing potential must not be pregnant or lactating and must be using adequate contraception.
- Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the test drug(s), including cardiovascular, renal, pulmonary, hepatic, gastrointestinal, endocrine/metabolic, haematological/oncological, neurological and psychiatric diseases.
- Patients within the last 6 months having a history of myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, heart failure, cerebrovascular accident, or transient ischemic attack.
- Patients with clinically significant elevations in laboratory values at Screening Visit.
- Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or Cushing's syndrome.
- Patients with contraindications for olmesartan medoxomil, hydrochlorothiazide, and/or amlodipine besylate.
Data sourced from ClinicalTrials.gov (NCT00311155). 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.