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Olmesartan Medoxomil in Atherosclerosis

NCT ID: NCT00185185

Last Updated: 2007-12-14

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

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2006-02-28

Brief Summary

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This is a study in hypertensive patients with atherosclerosis and increased cardiovascular risk. The efficacy of olmesartan medoxomil on atherosclerosis is measured.

Detailed Description

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Conditions

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Essential Hypertension Atherosclerotic Cardiovascular Disease

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

olmesartan medoxomil

Group Type EXPERIMENTAL

Olmesartan medoxomil

Intervention Type DRUG

Hydrochlorothiazide

Intervention Type DRUG

tablets

olmesartan medoxomil

Intervention Type DRUG

tablets

2

atenolol

Group Type ACTIVE_COMPARATOR

Atenolol

Intervention Type DRUG

Hydrochlorothiazide

Intervention Type DRUG

tablets

atenolol

Intervention Type DRUG

tablets

Interventions

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Olmesartan medoxomil

Intervention Type DRUG

Atenolol

Intervention Type DRUG

Hydrochlorothiazide

tablets

Intervention Type DRUG

olmesartan medoxomil

tablets

Intervention Type DRUG

atenolol

tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Mean sitting sBP and dBP prior to randomization of 140-180/90-105 mmHg
* Increased cardiovascular risk, e.g.: a) documented or clinical signs of peripheral atherosclerotic disease stage IIa or lower; b) diabetes mellitus type 2; c) left ventricular hypertrophy on echo; d) current smoking; e) old myocardial infarction, stroke or TIA
* Intima-media thickness of the common carotid artery greater than or equal to 0.8 and less than or equal to 1.6 mm (measured ultrasonographically) or the plaque volume of the carotid bulb greater than or equal to 4 μl and less than or equal to 500 μl

Exclusion Criteria

* Body mass index \> 30
* Any type of known secondary hypertension
* Electrocardiographic evidence of 2nd or 3rd degree atrioventricular block, atrial fibrillation, cardiac arrhythmia requiring therapy or bradycardia at rest (\< 50/min)
* Obstructive pulmonary disease
* Claudicatio intermittens
* History or clinical evidence of any significant gastrointestinal, respiratory, hematological, metabolic, immunological or any other underlying disease which in the opinion of the investigator would interfere with the patient's participation in the trial
* Hypersensitivity or contraindication to ARBs, Beta-Blockers, HCTZ or any cross allergy
* Pre-treatment with ARBs or ACE inhibitors within 6 months prior to screening
* Treatment with disallowed medication
* Pregnant or breastfeeding females or females of childbearing potential without adequate contraception
* History of alcohol and/or drug abuse
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sankyo Pharma Gmbh

INDUSTRY

Sponsor Role lead

Responsible Party

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Daichi Sankyo Europe, GmbH

Principal Investigators

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Prof. Klaus O Stumpe, MD

Role: PRINCIPAL_INVESTIGATOR

Medizinische Poliklinik der Friedrich-Wilhelms-Universitat, Bonn, Germany

Locations

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Munich, , Germany

Site Status

Countries

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Germany

References

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Clezar CN, Flumignan CD, Cassola N, Nakano LC, Trevisani VF, Flumignan RL. Pharmacological interventions for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2023 Aug 4;8(8):CD013573. doi: 10.1002/14651858.CD013573.pub2.

Reference Type DERIVED
PMID: 37565307 (View on PubMed)

Other Identifiers

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SE-866/27

Identifier Type: -

Identifier Source: org_study_id