Olmesartan and an add-on Treatment in Patients With Mild to Moderate Hypertension

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sankyo Pharma Gmbh
• Treatments: Amlodipine; Hydrochlorothiazide; Olmesartan; Olmesartan Medoxomil

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with normal or elevated blood pressure (BP) are eligible to participate if their pre-treatment medication can be withdrawn.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.