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Comparative Study of Valsartan and Amlodipine Versus Amlodipine Alone in Hypertension

NCT ID: NCT00333489

Last Updated: 2011-11-08

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

PHASE4

Total Enrollment

551 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2005-04-30

Brief Summary

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The objective of this study is to evaluate efficacy, safety and tolerability of the valsartan+amlodipine association in patients with mild to moderate essential hypertension, in comparison to amlodipine alone.

Patients should have mild to moderate essential hypertension \[grades 1 and 2 of WHO classification (8)\]. The diastolic blood pressure threshold for inclusion in this study is 95 mmHg, as these patients are more likely to benefit from association therapy than patients with lower diastolic blood pressure.

For safety reasons, patients with severe hypertension (grade 3 of WHO classification) will not be included in this study. Moreover, patients developing severe hypertension (MSDBP \> 110 mmHg and/or MSSBP \> 180 mmHg) during the open-label treatment phase will be discontinued from the study.

Detailed Description

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Conditions

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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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valsartan

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

* Severe hypertension (grade 3 of WHO classification: DBP \>= 110 mmHg and/or SBP ≥ 180 mmHg) or malignant hypertension.
* Inability to completely discontinue all antihypertensive medications safely for a period of at least 2 weeks as required by the protocol.
* Evidence of a secondary form of hypertension, such as coarctation of aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc.
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 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_CHAIR

Novartis Pharmaceuticals

Locations

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Novartis Pharmaceuticals

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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CVAL489ABR02

Identifier Type: -

Identifier Source: org_study_id