Olmesartan Medoxomil in Hypertension and Renal Impairment - Full Text View

Purpose

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

Condition	Intervention	Phase
Essential Hypertension Renal Impairment	Drug: Olmesartan medoxomil Drug: Losartan Drug: Furosemide oral tablets	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Drug Information available for: Furosemide Losartan Losartan potassium Olmesartan Olmesartan medoxomil

U.S. FDA Resources

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Response to treatment = mean sitting diastolic blood pressure less than or equal to 90 mmHg or reduction greater than or equal to 10 mmHg
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 ] [ Designated as safety issue: No ]
Changes in serum creatinine after 12 and 52 weeks of treatment [ Time Frame: Baseline to 12 and 52 weeks ] [ Designated as safety issue: No ]
Rate of patients per dose level after 12 and 52 weeks of treatment [ Time Frame: Baseline to 12 and 52 weeks ] [ Designated as safety issue: No ]
Change in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment [ Time Frame: Baseline to 4, 12, 24, 36 and 52 weeks ] [ Designated as safety issue: No ]


Enrollment:	393
Study Start Date:	August 2003
Study Completion Date:	July 2005
Primary Completion Date:	July 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151827

Locations


Germany

Darmstadt, Germany

Sponsors and Collaborators

Sankyo Pharma Gmbh

Investigators


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

More Information


ClinicalTrials.gov Identifier:	NCT00151827 History of Changes
Other Study ID Numbers:	SE-866/43
Study First Received:	September 8, 2005
Last Updated:	October 13, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on September 30, 2016