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Olmesartan Medoxomil Versus Losartan in Elderly and Very Elderly

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ClinicalTrials.gov Identifier: NCT00751751
Recruitment Status : Completed
First Posted : September 12, 2008
Last Update Posted : September 12, 2008
Sponsor:
Information provided by:
Daiichi Sankyo, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Essential Hypertension Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary Drug: losartan + hydrochlorothiazide, if necessary Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 441 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : June 2003
Actual Primary Completion Date : April 2005
Actual Study Completion Date : June 2005

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U.S. FDA Resources

Arm Intervention/treatment
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.



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

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT00751751


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

Responsible Party: Petra Laeis, Ph.D., Daiichi Sankyo Europe, GmbH
ClinicalTrials.gov Identifier: NCT00751751     History of Changes
Other Study ID Numbers: SE-866/36
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
Losartan
Olmesartan
Hydrochlorothiazide
Olmesartan Medoxomil
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators