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

Daiichi Sankyo

Status and phase: Completed; Phase 4

Conditions: Essential Hypertension

Treatments: Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary

Study type: Interventional

Funder types: Industry

Identifiers

NCT00311155

2005-004659-36 (EudraCT Number)

SP-OLM-03-05

Details and patient eligibility

About

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.

Enrollment: 694 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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with normal or elevated blood pressure (BP) are eligible to participate if their pre-treatment medication can be withdrawn.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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

694 participants in 1 patient group

1

Experimental group

Description:

Olmesartan medoxomil oral tablets for 4 weeks followed by, if necessary: Olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets for 8 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets + amlodipine oral tablets for 8 weeks

Treatment:

Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary