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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.

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.

Condition or disease Intervention/treatment Phase
Isolated Systolic Hypertension Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary Drug: nitrendipine + hydrochlorothiazide, if necessary Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 417 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy of Olmesartan Medoxomil Versus Nitrendipine on Systolic Blood Pressure in Elderly and Very Elderly Patients With Isolated Systolic Hypertension
Study Start Date : July 2003
Actual Primary Completion Date : October 2004
Actual Study Completion Date : February 2005

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Arm Intervention/treatment
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
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

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
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




Primary Outcome Measures :
  1. Change in mean sitting systolic blood pressure as assessed by conventional BP measurements [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00751829


Locations
Germany
Munich, Germany
Sponsors and Collaborators
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Investigators
Principal Investigator: Peter U Witte, MD, Ph.D. IMFORM GmbH

Responsible Party: Petra Laeis, Ph.D., Daiichi Sankyo Europe, GmbH
ClinicalTrials.gov Identifier: NCT00751829     History of Changes
Other Study ID Numbers: SE-866/37
First Posted: September 12, 2008    Key Record Dates
Last Update Posted: September 12, 2008
Last Verified: September 2008

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Olmesartan
Hydrochlorothiazide
Olmesartan Medoxomil
Nitrendipine
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Calcium Channel Blockers
Vasodilator Agents