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Efficacy and Safety of Valsartan/Amlodipine Combination in Hypertensive Patients Not Controlled With Amlodipine Alone

NCT ID: NCT00171002

Last Updated: 2023-12-14

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

936 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2005-06-30

Brief Summary

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This study will test the effectiveness and safety of a combination treatment in patients whose blood pressure is not controlled with a single medication

Detailed Description

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Conditions

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Hypertension

Keywords

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Hypertension, high blood pressure, valsartan, amlodipine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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valsartan/amlodipine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with uncomplicated, essential hypertension

Exclusion Criteria

* Severe hypertension
* History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
* Liver, kidney, or pancreas disease
* Insulin dependent diabetes
* Allergy to certain medications used to treat high blood pressure
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Multiple Locations, , Germany

Site Status

Novartis Pharmaceuticals

Basel, , Switzerland

Site Status

Countries

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Germany Switzerland

References

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Schunkert H, Glazer RD, Wernsing M, Yen J, Macarie CE, Vintila MM, Romanova J. Efficacy and tolerability of amlodipine/valsartan combination therapy in hypertensive patients not adequately controlled on amlodipine monotherapy. Curr Med Res Opin. 2009 Nov;25(11):2655-62. doi: 10.1185/03007990903251193.

Reference Type DERIVED
PMID: 19751115 (View on PubMed)

Other Identifiers

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CVAA489A2306

Identifier Type: -

Identifier Source: org_study_id