Olmesartan Medoxomil in Hypertension and Renal Impairment

Efficacy and Safety of Olmesartan Medoxomil Compared With Losartan in Patients With Hypertension and Mild to Moderate Renal Impairment

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

Study Overview

• Status: Completed
• Conditions: Renal Impairment; Essential Hypertension
• Intervention / Treatment: Drug: Olmesartan medoxomil; Drug: Furosemide oral tablets; Drug: Losartan

• Study Type: Interventional
• Enrollment (Actual): 393
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Darmstadt, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Olmesartan medoxomil; Olmesartan oral tablets 20 mg or 40 mg + losartan placebo. Medications are taken once daily before breakfast with water.	Drug: Olmesartan medoxomil; Olmesartan oral tablets 20 or 40 mg + losartan placebo. Medications are taken once daily before breakfast with water.; 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
Experimental: Losartan; Losartan over encapsulated tablets 50 mg and 100 mg plus olmesartan placebo.	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; Drug: Losartan; Medications are taken once daily before breakfast with water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in mean sitting diastolic blood pressure (dBP), assessed by conventional blood pressure measurements after 12 weeks of treatment	Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean sitting diastolic blood pressure, assessed by conventional blood pressure measurements after 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks of treatment;		Baseline to 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks
Change in mean sitting systolic blood pressure, assessed by conventional blood pressure measurements after 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks of treatment;		Baseline to 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks
Response to treatment after 1, 2, 4, 8, 12, 18, 24, 30, 36, 44 and 52 weeks of treatment;	Response to treatment = mean sitting diastolic blood pressure less than or equal to 90 mmHg or reduction greater than or equal to 10 mmHg	Baseline to 1, 2, 4, 8, 12, 18, 24, 30, 36, 44 and 52 weeks
Changes in creatinine clearance after 12 and 52 weeks of treatment, changes in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment;		Baseline to 12 and 52 weeks
Changes in serum creatinine after 12 and 52 weeks of treatment		Baseline to 12 and 52 weeks
Rate of patients per dose level after 12 and 52 weeks of treatment		Baseline to 12 and 52 weeks
Change in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment		Baseline to 4, 12, 24, 36 and 52 weeks

Collaborators and Investigators

• Sponsor: Sankyo Pharma Gmbh
• Investigators: Principal Investigator: P. U. Witte, MD, PhD, IMFORM GmbH, Darmstadt, Germany

Study record dates

Study Major Dates

• Study Start: August 1, 2003
• Primary Completion (Actual): July 1, 2005
• Study Completion (Actual): July 1, 2005

Study Registration Dates

• First Submitted: September 8, 2005
• First Submitted That Met QC Criteria: September 8, 2005
• First Posted (Estimate): September 9, 2005

Study Record Updates

• Last Update Posted (Estimate): October 14, 2010
• Last Update Submitted That Met QC Criteria: October 13, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Hypertension; Renal Insufficiency; Essential Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Potassium Chloride Symporter Inhibitors; Losartan; Olmesartan; Olmesartan Medoxomil; Furosemide
• Other Study ID Numbers: SE-866/43