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Olmesartan as an add-on to Amlodipine in Hypertension

NCT ID: NCT00220233

Last Updated: 2018-12-24

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

632 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2007-08-31

Brief Summary

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This study is to test the efficacy and safety of the combination of olmesartan and amlodipine in hypertensive patients whose blood pressure is not adequately controlled with amlodipine alone

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

NONE

Interventions

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olmesartan medoxomil

Intervention Type DRUG

amlodipine

Intervention Type DRUG

hydrochlorothiazide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Without antihypertensive pre-treatment mean seated BP greater than 160/100 mmHg
* Pre-treatment with amlodipine 5 or 10 mg: mean seated BP greater than or equal to 140/90 mmHg

Exclusion Criteria

* Secondary hypertension
* Any serious disorder which may limit the ability to evaluate the efficacy or safety of the test drugs
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sankyo Pharma Gmbh

INDUSTRY

Sponsor Role lead

Principal Investigators

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Peter Brommer, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Leipzig, , Germany

Site Status

Sinsheim, , Germany

Site Status

Tann, , Germany

Site Status

Weinheim, , Germany

Site Status

Wiesbaden, , Germany

Site Status

Countries

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Germany

Other Identifiers

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CS8663-A-E303

Identifier Type: -

Identifier Source: org_study_id