Olmesartan in Essential Hypertension

Phase 3CompletedNCT00185172

Sankyo Pharma Gmbh2,333 enrolled

Overview

To test the efficacy and safety of olmesartan in patients with essential hypertension.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

2,333

Conditions

Essential Hypertension

Interventions

placeboOTHER

Placebo oral tablets for 2 weeks

olmesartan medoxomilDRUG

olmesartan medoxomil oral tablets for 8 weeks

olmesartan medoxomil oral tablets, hydrochlorothiazide oral tabletsDRUG

olmesartan medoxomil oral tablets,or olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age: 18 (19 if required by local authorities) to 75 years * Males and females of any race. Female participants must take adequate contraceptive measures (oral contraceptives, I.U.D.), be post-menopausal or surgically sterilized * Essential hypertension: sitting DBP greater than or equal to 90 and less than 110 mmHg * Written Informed Consent * Mentally competent * Negative pregnancy test in women at a childbearing age at the beginning of the study Exclusion Criteria: * Patients with known severe (World Health Organization (WHO) stage III, sitting DBP stable at greater than or equal to 110 mmHg), malignant or secondary hypertension * Patients who have had a myocardial infarction or percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) within the last 6 months * Patients with a history or current evidence of congestive heart failure * Bilateral renal artery stenosis * Severe renal insufficiency (serum creatinine greater than 200 micro mol/l) * Severe hepatic impairment or biliary obstruction

Locations (8)

Result Cro

Vienna, Austria

INPUT GmbG

Aachen, Germany

Biokos Farma s.r.l.

Bologna, Italy

IMRO TRAMARKO International bv

Berghem, Netherlands

Outcomes

Primary Outcomes

To compare the efficacy on diastolic blood pressure of 40 mg olmesartan to a combination of 20 mg olmesartan and 12.5 mg hydrochlorothiazide in patients who are not sufficiently responding to treatment with 20 mg olmesartan.

Time frame: From week 8 to week 12

Secondary Outcomes

To assess the effects on systolic and diastolic blood pressure of 20 mg olmesartan, 40 mg olmesartan and the combination of 20 mg olmesartan with 12.5 mg hydrochlorothiazide at week 2, 4, 8 and 12.

Time frame: 12 weeks

To detect less frequent adverse drug reactions and assess the safety and tolerability of olmesartan.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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