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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00185185
Other study ID # SE-866/27
Secondary ID
Status Completed
Phase Phase 3
First received September 12, 2005
Last updated December 12, 2007
Start date November 2001
Est. completion date February 2006

Study information

Verified date December 2007
Source Daiichi Sankyo Inc.
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 165
Est. completion date February 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 35 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Olmesartan medoxomil

Atenolol

Hydrochlorothiazide
tablets
olmesartan medoxomil
tablets
atenolol
tablets

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sankyo Pharma Gmbh

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of intima media thickness of the common carotid artery on the leading side of the neck.
Secondary -Change in plaque volume in the common carotid artery or the carotid bulb.
Secondary -Change of intima media thickness of the common carotid artery.
Secondary -Changes of diastolic and systolic blood pressure.
Secondary -Safety and tolerability
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