Olmesartan Medoxomil in Hypertension and Renal Impairment

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Essential Hypertension; Renal Impairment	Drug: Olmesartan medoxomil; Drug: Losartan; Drug: Furosemide oral tablets	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	393 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Efficacy and Safety of Olmesartan Medoxomil Compared With Losartan in Patients With Hypertension and Mild to Moderate Renal Impairment
Study Start Date :	August 2003
Actual Primary Completion Date :	July 2005
Actual Study Completion Date :	July 2005

Arms and Interventions

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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: Losartan; 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

Outcome Measures

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Primary Outcome Measures :

1. Change in mean sitting diastolic blood pressure (dBP), assessed by conventional blood pressure measurements after 12 weeks of treatment [ Time Frame: Baseline to 12 weeks ]

Secondary Outcome Measures :

1. 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; [ Time Frame: Baseline to 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks ]
2. 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; [ Time Frame: Baseline to 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks ]
3. Response to treatment after 1, 2, 4, 8, 12, 18, 24, 30, 36, 44 and 52 weeks of treatment; [ Time Frame: Baseline to 1, 2, 4, 8, 12, 18, 24, 30, 36, 44 and 52 weeks ]
   Response to treatment = mean sitting diastolic blood pressure less than or equal to 90 mmHg or reduction greater than or equal to 10 mmHg
4. Changes in creatinine clearance after 12 and 52 weeks of treatment, changes in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment; [ Time Frame: Baseline to 12 and 52 weeks ]
5. Changes in serum creatinine after 12 and 52 weeks of treatment [ Time Frame: Baseline to 12 and 52 weeks ]
6. Rate of patients per dose level after 12 and 52 weeks of treatment [ Time Frame: Baseline to 12 and 52 weeks ]
7. Change in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment [ Time Frame: Baseline to 4, 12, 24, 36 and 52 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Germany
Darmstadt, Germany

Sponsors and Collaborators

Sankyo Pharma Gmbh

Investigators

Principal Investigator:	P. U. Witte, MD, PhD	IMFORM GmbH, Darmstadt, Germany

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00151827 History of Changes
Other Study ID Numbers:	SE-866/43
First Posted:	September 9, 2005
Last Update Posted:	October 14, 2010
Last Verified:	October 2010

Additional relevant MeSH terms:

Hypertension; Renal Insufficiency; Vascular Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Losartan; Olmesartan; Olmesartan Medoxomil; Furosemide	Anti-Arrhythmia Agents; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Molecular Mechanisms of Pharmacological Action; Diuretics; Natriuretic Agents; Physiological Effects of Drugs; Sodium Potassium Chloride Symporter Inhibitors; Membrane Transport Modulators