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Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Therapy in Patients With Hypertension

NCT ID: NCT00280540

Last Updated: 2010-11-09

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

648 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Brief Summary

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This is a double-blind study to evaluate the reduction in systolic blood pressure using a therapy initiated with valsartan 160 mg or valsartan + hydrochlorothiazide (HCTZ) 160/12.5 mg compared to a more conventional approach (therapy initiated with low-dose valsartan 80 mg).

Detailed Description

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Conditions

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Hypertension

Keywords

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Hypertension High blood pressure Blood pressure control Blood pressure reduction Valsartan

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/Hydrochlorothiazide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female age 18 or older
* Diagnosed as having hypertension (mean seated systolic blood pressure ≥ 150 mm Hg but \< 180 mm Hg and mean seated diastolic blood pressure ≥ 90 mm Hg and \<110 mm Hg)

Exclusion Criteria

* Patients with severe hypertension: Systolic ≥ 180 mm Hg or Diastolic ≥ 110 mm Hg
* History of secondary hypertension (including primary aldosteronism, renovascular hypertension, pheochromocytoma etc.)
* History of myocardial infarction, stroke \[e.g. cerebrovascular accident (CVA), thrombotic stroke, transient ischemic attack (TIA)\], or onset of heart failure within the last 6 months.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis

Locations

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Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Site Status

Countries

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United States

References

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Zappe DH, Palmer BF, Calhoun DA, Purkayastha D, Samuel R, Jamerson KA. Effectiveness of initiating treatment with valsartan/hydrochlorothiazide in patients with stage-1 or stage-2 hypertension. J Hum Hypertens. 2010 Jul;24(7):483-91. doi: 10.1038/jhh.2009.90. Epub 2009 Dec 10.

Reference Type DERIVED
PMID: 20010618 (View on PubMed)

Other Identifiers

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CVAH631BUS05

Identifier Type: -

Identifier Source: org_study_id