Treat-to-target study of olmesartan medoxomil and an add-on treatment algorithm consisting of hydrochlorothiazide and amlodipine besylate in patients with mild to moderate hypertension - Treat to target - OLMETREAT

• Conditions: Mild to moderate hypertension

• Registration Number: EUCTR2005-004659-36-DE
• Lead Sponsor: Daiichi Sankyo Europe GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-29
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 720

Inclusion Criteria

Male and female patients age = 18 years with mild to moderate hypertension.

Pre-treated patients with normal or elevated blood pressure are eligible to participate if their pre-treatment can be withdrawn.

At the end of the placebo run-in period sitting sBP =140 and < 180 mmHg and/or sitting dBP =90 and < 110 mmHg at trough (When a patient’s systolic and diastolic blood pressures fall into different categories the higher category will apply to define on mild or moderate hypertension).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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, pheocromocytoma, or Cushing’s syndrome.

Patients with contra-indications for olmesartan medoxomil, hydrochlorothiazide, and/or amlodipine besylate.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified