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Isolated Systolic Hypertension in the Elderly and Very Elderly

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00751829
First received: September 11, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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 Intervention Phase
Isolated Systolic Hypertension
 Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary
Drug: nitrendipine + hydrochlorothiazide, if necessary
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Change in mean sitting systolic blood pressure as assessed by conventional BP measurements [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 417
Study Start Date: July 2003
Study Completion Date: February 2005
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00751829

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

No publications provided

Responsible Party: Petra Laeis, Ph.D., Daiichi Sankyo Europe, GmbH
ClinicalTrials.gov Identifier: NCT00751829     History of Changes
Other Study ID Numbers: SE-866/37
Study First Received: September 11, 2008
Last Updated: September 11, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on May 16, 2013