Olmesartan Medoxomil in Hypertension and Renal Impairment

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00151827
First received: September 8, 2005
Last updated: October 13, 2010
Last verified: October 2010
  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:


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
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
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

No publications provided

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
Furosemide
Losartan
Olmesartan medoxomil
Olmesartan
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on April 17, 2014