Olmesartan Medoxomil Versus Losartan in Elderly and Very Elderly

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00751751
First received: September 11, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

To assess the efficacy of individually optimized doses of olmesartan medoxomil compared to losartan in elderly and very elderly patients with essential hypertension. The study hypothesis is non-inferiority of olmesartan medoxomil compared to losartan in lowering mean sitting diastolic blood pressure after 12 weeks of treatment compared to baseline. The study duration is up to 60 weeks, including a 52-week treatment period. After 12 weeks of treatment hydrochlorothiazide may be added to control blood pressure. Efficacy and safety measurements are carried out at up to 18 visits during the trial.


Condition Intervention Phase
Essential Hypertension
Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary
Drug: losartan + 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 Losartan on Diastolic Blood Pressure in Elderly and Very Elderly Patients With Essential Hypertension.

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

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

Secondary Outcome Measures:
  • Change in mean sitting diastolic BP assessed by conventional BP measurements [ Time Frame: after 1, 2, 4, 8, 16, 20, 28, 36, 44, and 52 weeks ] [ Designated as safety issue: No ]
  • Change in mean standing diastolic BP, mean sitting systolic BP and mean standing systolic BP [ Time Frame: after 1, 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 441
Study Start Date: June 2003
Study Completion Date: June 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
oral olmesartan medoxomil tablets 20 or 40 mg taken once daily for 52 weeks + hydrochlorothiazide tablets 12.5 or 25 mg , if needed to control BP after 12 weeks
Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary
oral olmesartan medoxomil tablets taken once daily for 52 weeks + oral hydrochlorothiazide tablets, once daily, after 12 weeks if needed to control BP
Active Comparator: 2
oral losartan capsules, 50 or 100 mg taken once daily for 52 weeks + 12.5 or 25 mg oral hydrochlorothiazide tables, after 12 weeks, if needed to control BP.
Drug: losartan + hydrochlorothiazide, if necessary
oral losartan capsules, 50 or 100 mg taken once daily for 52 weeks + 12.5 or 25 mg oral hydrochlorothiazide tablets, 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 years or older
  • Mean sitting diastolic BP = 100-114 mmHg and mean sitting systolic BP >=150 mm HG

Exclusion Criteria:

  • Secondary hypertension
  • Malignant hypertension
  • Severe heart failure (NYHA III-IV)
  • History or evidence of renal disease
  • Recent history of myocardial infarction
  • Hypersensitivity to study drugs
  • History of drug or alcohol abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751751

Locations
Germany
Darmstadt, 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: NCT00751751     History of Changes
Other Study ID Numbers: SE-866/36
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
Losartan
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
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on July 22, 2014