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Olmesartan Medoxomil Versus Losartan in Elderly and Very Elderly

NCT ID: NCT00751751

Last Updated: 2008-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

441 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2005-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Essential Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

olmesartan medoxomil + hydrochlorothiazide, if necessary

Intervention Type DRUG

oral olmesartan medoxomil tablets taken once daily for 52 weeks + oral hydrochlorothiazide tablets, once daily, after 12 weeks if needed to control BP

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.

Group Type ACTIVE_COMPARATOR

losartan + hydrochlorothiazide, if necessary

Intervention Type DRUG

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.

Interventions

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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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Daiichi Sankyo Europe, GmbH

Principal Investigators

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Peter U Witte, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

IMFORM GmbH

Locations

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Darmstadt, , Germany

Site Status

Countries

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Germany

Other Identifiers

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SE-866/36

Identifier Type: -

Identifier Source: org_study_id