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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.

September 11, 2008
September 12, 2008
September 12, 2008
July 2003
October 2004   (Final data collection date for primary outcome measure)
Change in mean sitting systolic blood pressure as assessed by conventional BP measurements [ Time Frame: 12 weeks ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Isolated Systolic Hypertension in the Elderly and Very Elderly
Comparison of the Efficacy of Olmesartan Medoxomil Versus Nitrendipine on Systolic Blood Pressure in Elderly and Very Elderly Patients With Isolated Systolic Hypertension
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Isolated Systolic Hypertension
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
417
Same as current
February 2005
October 2004   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
65 Years and older   (Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00751829
SE-866/37
No
Not Provided
Not Provided
Petra Laeis, Ph.D., Daiichi Sankyo Europe, GmbH
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Not Provided
Principal Investigator: Peter U Witte, MD, Ph.D. IMFORM GmbH
Daiichi Sankyo, Inc.
September 2008

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