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Olmesartan Medoxomil in Hypertension and Renal Impairment

This study has been completed.
Information provided by Daiichi Sankyo Inc.

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Descriptive Information Fields
Brief Title  Olmesartan Medoxomil in Hypertension and Renal Impairment
Official Title  Efficacy and Safety of Olmesartan Medoxomil Compared With Losartan in Patients With Hypertension and Mild to Moderate Renal Impairment
Brief Summary

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

Detailed Description
Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  Change in mean sitting diastolic blood pressure (dBP), assessed by conventional BP measurements after 12 weeks of treatment
Secondary Outcome Measure  - 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.
Condition  Essential Hypertension
Renal Impairment
Intervention  Drug: Olmesartan medoxomil
Drug: Losartan
Drug: Furosemide
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  400
Start Date  August 2003
Completion Date February 2006
Eligibility 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
Gender Both
Ages 18 Years to 75 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  Germany
Administrative Information Fields
NCT ID  NCT00151827
Organization ID SE-866/43
Secondary IDs ††
Study Sponsor  Sankyo Pharma Gmbh
Collaborators ††
Investigators 
Principal Investigator:     P. U. Witte, MD, PhD     IMFORM GmbH, Darmstadt, Germany    
Information Provided By Daiichi Sankyo Inc.
Verification Date October 2007
First Received Date  September 8, 2005
Last Updated Date October 11, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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