Status:
COMPLETED
Olmesartan and an add-on Treatment in Patients With Mild to Moderate Hypertension
Lead Sponsor:
Sankyo Pharma Gmbh
Conditions:
Essential Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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
- 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with normal or elevated blood pressure (BP) are eligible to participate if their pre-treatment medication can be withdrawn.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
- 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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
694 Patients enrolled
Trial Details
Trial ID
NCT00311155
Start Date
March 1 2006
End Date
April 1 2008
Last Update
December 10 2010
Active Locations (79)
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1
Fulpmes, Austria, 6166
2
University Klinik, F. Innere Medizin
Innsbruck, Austria, 6020
3
Innsbruck, Austria, 6020
4
Kundl, Austria, 6250