Olmesartan Medoxomil Versus Losartan in Elderly and Very Elderly - Full Text View

Sponsored by:	Daiichi Sankyo Europe, GmbH
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00751751

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 III

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Losartan Losartan potassium Olmesartan Olmesartan medoxomil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of the Efficacy of Olmesartan Medoxomil Versus Losartan on Diastolic Blood Pressure in Elderly and Very Elderly Patients With Essential Hypertension.

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
1: Experimental 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
2: Active Comparator 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

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:	Daiichi Sankyo Europe, GmbH ( Petra Laeis, Ph.D. )
Study ID Numbers:	SE-866/36
Study First Received:	September 11, 2008
Last Updated:	September 11, 2008
ClinicalTrials.gov Identifier:	NCT00751751 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Essential Hypertension
Losartan
Diuretics
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Olmesartan medoxomil
Cardiovascular Agents

Antihypertensive Agents
Angiotensin II
Hydrochlorothiazide
Angiotensin II Type 1 Receptor Blockers
Anti-Arrhythmia Agents
Hypertension

Additional relevant MeSH terms:

Losartan
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Olmesartan medoxomil
Cardiovascular Agents
Antihypertensive Agents

Hydrochlorothiazide
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Anti-Arrhythmia Agents
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009