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Olmesartan Medoxomil in Hypertension and Renal Impairment

This study has been completed.

Sponsored by: Sankyo Pharma Gmbh
Information provided by: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00151827
  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
Phase III

Genetics Home Reference related topics:   Kidney Diseases  

MedlinePlus related topics:   High Blood Pressure   Kidney Diseases  

ChemIDplus related topics:   Losartan potassium   Losartan   Furosemide   Olmesartan   Olmesartan medoxomil  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Efficacy and Safety of Olmesartan Medoxomil Compared With Losartan in Patients With Hypertension and Mild to Moderate Renal Impairment

Further study details as provided by Daiichi Sankyo Inc.:

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

Secondary Outcome 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.

Estimated Enrollment:   400
Study Start Date:   August 2003
Estimated Study Completion Date:   February 2006

  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

Study ID Numbers:   SE-866/43
First Received:   September 8, 2005
Last Updated:   October 11, 2007
ClinicalTrials.gov Identifier:   NCT00151827
Health Authority:   Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:
Losartan
Vascular Diseases
Olmesartan medoxomil
Essential hypertension
Angiotensin II
Furosemide
Hypertension

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Membrane Transport Modulators
Angiotensin II Type 1 Receptor Blockers
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Anti-Arrhythmia Agents
Sodium Potassium Chloride Symporter Inhibitors

ClinicalTrials.gov processed this record on May 08, 2008