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Trial record 83 of 135 for:    OLMESARTAN

Isolated Systolic Hypertension in the Elderly and Very Elderly

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ClinicalTrials.gov Identifier: NCT00751829
Recruitment Status : Completed
First Posted : September 12, 2008
Last Update Posted : September 12, 2008
Sponsor:
Information provided by:
Daiichi Sankyo, Inc.

Tracking Information
First Submitted Date  ICMJE September 11, 2008
First Posted Date  ICMJE September 12, 2008
Last Update Posted Date September 12, 2008
Study Start Date  ICMJE July 2003
Actual Primary Completion Date October 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2008)
Change in mean sitting systolic blood pressure as assessed by conventional BP measurements [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2008)
  • Change in mean sitting systolic blood pressure assessed by conventional BP measurements [ Time Frame: After 1, 2, 4, 8, 12, 16, 20, and 24 weeks ]
  • Change in mean standing systolic BP, mean sitting diastolic BP and mean standing diastolic BP [ Time Frame: after 1, 2, 4, 8, 12, 16, 20, and 24 weeks of treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Isolated Systolic Hypertension in the Elderly and Very Elderly
Official Title  ICMJE Comparison of the Efficacy of Olmesartan Medoxomil Versus Nitrendipine on Systolic Blood Pressure in Elderly and Very Elderly Patients With Isolated Systolic Hypertension
Brief Summary To evaluate the efficacy of long-term treatment of individually optimized doses of olmesartan medoxomil compared to nitrendipine in elderly and very elderly patients with isolated systolic hypertension. The study hypothesis is non-inferiority of olmesartan medoxomil compared to nitrendipine in lowering mean sitting systolic blood pressure after 12 weeks of treatment compared to baseline. The study duration is up to 32 weeks, including a 24-week treatment period. After 12 weeks hydrochlorothiazide may be added to control blood pressure. Efficacy and safety measurements are carried out at up to 15 visits during the trial period.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Isolated Systolic Hypertension
Intervention  ICMJE
  • Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary
    oral olmesartan medoxomil tablets 20 mg or 40 mg once daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to control BP
  • Drug: nitrendipine + hydrochlorothiazide, if necessary
    oral nitrendipine tablets 10 or 20 mg taken twice daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to control BP
Study Arms  ICMJE
  • Experimental: 1
    oral olmesartan medoxomil tablets 20 mg or 40 mg once daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to controll BP
    Intervention: Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary
  • Active Comparator: 2
    oral nitrendipine tablets 10 or 20 mg taken twice daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to control BP
    Intervention: Drug: nitrendipine + hydrochlorothiazide, if necessary
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 11, 2008)
417
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2005
Actual Primary Completion Date October 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 65 or older
  • Mean sitting BP >160 mmHg and mean sitting dBP<90 mmHg

Exclusion Criteria:

  • Secondary hypertension
  • Malignant hypertension
  • Severe Heart Failure (NYHA III-IV)
  • Recent history of myocardial infarction
  • Hypersensitivity to study medications
  • History of drug or alcohol abuse
  • History or evidence of renal disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00751829
Other Study ID Numbers  ICMJE SE-866/37
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Petra Laeis, Ph.D., Daiichi Sankyo Europe, GmbH
Study Sponsor  ICMJE Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter U Witte, MD, Ph.D. IMFORM GmbH
PRS Account Daiichi Sankyo, Inc.
Verification Date September 2008

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