Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Olmesartan medoxomil
• Drug: Losartan
• Drug: Furosemide

Primary Measures

• Change in mean sitting diastolic blood pressure (dBP), assessed by conventional BP measurements after 12 weeks of treatment

Secondary Measures

• - Change in mean sitting dBP, assessed by conventional BP measurements after 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks of treatment;
• - Change in mean sitting sBP, assessed by conventional BP measurements after 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks of treatment;
• - Response to treatment (i.e. mean sitting dBP less than or equal to 90 mmHg or reduction greater than or equal to 10 mmHg) after 1, 2, 4, 8, 12, 18, 24, 30, 36, 44 and 52 weeks of treatment;
• - Changes in CLcr and serum creatinine after 12 and 52 weeks of treatment, changes in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment;
• - Onset of BP lowering effect;
• - Rate of patients per dose level after 12 and 52 weeks of treatment;
• - Safety and tolerability.

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sankyo Pharma Gmbh

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on November 18, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00151827

Study ID Number: SE-866/43

ClinicalTrials.gov Identifier: NCT00151827

Health Authority: Germany: Federal Institute for Drugs and Medical Devices