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Olmesartan Medoxomil in Hypertension and Renal Impairment
This study has been completed.
Study NCT00151827   Information provided by Daiichi Sankyo Inc.
First Received: September 8, 2005   Last Updated: October 11, 2007   History of Changes

September 8, 2005
October 11, 2007
August 2003
 
Change in mean sitting diastolic blood pressure (dBP), assessed by conventional BP measurements after 12 weeks of treatment
Same as current
Complete list of historical versions of study NCT00151827 on ClinicalTrials.gov Archive Site
  • - 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.
  • - Change in mean sitting dBP, assessed by conventional BP
  • measurements
  • - Change in mean sitting sBP, assessed by conventional BP
  • - Response to treatment (i.e. mean sitting dBP less than
  • or equal to 90 mmHg or reduction greater than or equal to
  • 10 mmHg)
  • - Changes in CLcr and serum creatinine after 12 and 52
  • weeks of treatment, changes in proteinuria
  • - Onset of BP lowering effect
  • - Safety and tolerability
 
Olmesartan Medoxomil in Hypertension and Renal Impairment
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.

 
Phase III
Interventional
Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
  • Essential Hypertension
  • Renal Impairment
  • Drug: Olmesartan medoxomil
  • Drug: Losartan
  • Drug: Furosemide
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
400
February 2006
 

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00151827
 
SE-866/43
Sankyo Pharma Gmbh
 
Principal Investigator: P. U. Witte, MD, PhD IMFORM GmbH, Darmstadt, Germany
Daiichi Sankyo Inc.
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP