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

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

ChemIDplus related topics:

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

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

Study placed in the following topic categories:

Losartan

Vascular Diseases

Olmesartan medoxomil

Essential hypertension

Angiotensin II

Hydrochlorothiazide

Hypertension

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action

Diuretics

Physiological Effects of Drugs

Sodium Chloride Symporter Inhibitors

Cardiovascular Agents

Antihypertensive Agents

Pharmacologic Actions

Membrane Transport Modulators

Angiotensin II Type 1 Receptor Blockers

Natriuretic Agents

Therapeutic Uses

Cardiovascular Diseases

Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on October 06, 2008

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