Olmesartan Medoxomil in Hypertension and Renal Impairment

Essential Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00151827
• Other study ID #: SE-866/43
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: October 13, 2010
• Start date: August 2003
• Est. completion date: July 2005

Study information

• Verified date: October 2010
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 393
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension
• Renal Impairment
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sankyo Pharma Gmbh

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean sitting diastolic blood pressure (dBP), assessed by conventional blood pressure measurements after 12 weeks of treatment		Baseline to 12 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Changes in serum creatinine after 12 and 52 weeks of treatment		Baseline to 12 and 52 weeks	No
Secondary	Rate of patients per dose level after 12 and 52 weeks of treatment		Baseline to 12 and 52 weeks	No
Secondary	Change in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment		Baseline to 4, 12, 24, 36 and 52 weeks	No