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Amlodipine as add-on to Olmesartan in Hypertension

NCT ID: NCT00220220

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

429 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2007-04-30

Brief Summary

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Test the efficacy and safety of the combination of olmesartan and amlodipine in hypertensive patients whose blood pressure is not adequately controlled with olmesartan 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

DOUBLE

Interventions

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olmesartan medoxomil

Intervention Type DRUG

amlodipine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Mean sitting BP of greater than or equal to 140/90-115 mmHg and mean 24h dBP greater than or equal to 80 mmHg with at least 30% of daytime readings greater than 85 mmHg prior to randomization.

Exclusion Criteria

* Secondary hypertension of any aetiology;
* Any serious disorders which may limit the ability to evaluate the efficacy or safety of the test drug(s);
* History of myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, congestive heart failure, hypertensive encephalopathy, stroke or TIA within the last 6 months.
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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Hamburg, , Germany

Site Status

Magdeburg, , Germany

Site Status

Messkirch, , Germany

Site Status

Stuhr, , Germany

Site Status

Tann, , Germany

Site Status

Worpswede, , Germany

Site Status

Countries

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Germany

References

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Barrios V, Brommer P, Haag U, Calderon A, Escobar C. Olmesartan medoxomil plus amlodipine increases efficacy in patients with moderate-to-severe hypertension after monotherapy: a randomized, double-blind, parallel-group, multicentre study. Clin Drug Investig. 2009;29(7):427-439. doi: 10.2165/00044011-200929070-00001.

Reference Type DERIVED
PMID: 19499960 (View on PubMed)

Other Identifiers

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CS8663-A-E302

Identifier Type: -

Identifier Source: org_study_id