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Olmesartan Medoxomil in Hypertension and Renal Impairment

NCT ID: NCT00151827

Last Updated: 2010-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

393 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2005-07-31

Brief Summary

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This is a study in hypertensive patients with mild to moderate renal impairment. The antihypertensive efficacy of olmesartan medoxomil is compared to losartan.

Detailed Description

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Conditions

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Essential Hypertension Renal Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Olmesartan medoxomil

Olmesartan oral tablets 20 mg or 40 mg + losartan placebo. Medications are taken once daily before breakfast with water.

Group Type EXPERIMENTAL

Olmesartan medoxomil

Intervention Type DRUG

Olmesartan oral tablets 20 or 40 mg + losartan placebo. Medications are taken once daily before breakfast with water.

Furosemide oral tablets

Intervention Type DRUG

If its use is necessary, the dose of furosemide allowed is 20 to 120 mg per day at the discretion of the investigator

Losartan

Losartan over encapsulated tablets 50 mg and 100 mg plus olmesartan placebo.

Group Type EXPERIMENTAL

Losartan

Intervention Type DRUG

Medications are taken once daily before breakfast with water.

Furosemide oral tablets

Intervention Type DRUG

If its use is necessary, the dose of furosemide allowed is 20 to 120 mg per day at the discretion of the investigator

Interventions

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Olmesartan medoxomil

Olmesartan oral tablets 20 or 40 mg + losartan placebo. Medications are taken once daily before breakfast with water.

Intervention Type DRUG

Losartan

Medications are taken once daily before breakfast with water.

Intervention Type DRUG

Furosemide oral tablets

If its use is necessary, the dose of furosemide allowed is 20 to 120 mg per day at the discretion of the investigator

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Mean sitting BP prior to randomization of 140-180/90-109 mmHg;
* Renal impairment prior to randomization of mild (50 ≤ CLcr ≥ 80 mL/min) to moderate (30 ≤ CLcr ≥50 mL/min) severity

Exclusion Criteria

* Malignant hypertension or sitting BP greater than 180/109 mmHg;
* Severe heart failure, severe renal disease;
* Recent history of myocardial infarction, stroke or transient ischemic attack;
* History, clinical or current evidence of any significant gastrointestinal, respiratory, hematological, metabolic, immunological or any other underlying disease which in the opinion of the investigator would interfere with the patient's participation in the trial;
* Hypersensitivity or contraindications to ARBs or ACE inhibitors or any cross allergy;
* Treatment with dis-allowed medication;
* Pregnant or breastfeeding females or females of childbearing potential without adequate contraception;
* History of drug and/or alcohol abuse
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sankyo Pharma Gmbh

INDUSTRY

Sponsor Role lead

Principal Investigators

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P. U. Witte, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

IMFORM GmbH, Darmstadt, Germany

Locations

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Darmstadt, , Germany

Site Status

Countries

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Germany

Other Identifiers

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SE-866/43

Identifier Type: -

Identifier Source: org_study_id