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Effects of Blood Pressure Reduction on High Sensitivity C-Reactive Protein (hsCRP)

NCT ID: NCT00154271

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

1677 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2005-06-30

Brief Summary

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The study compares the efficacy of an aggressive versus a moderate initial antihypertensive regimen to reduce blood pressure in patients with Stage 2 hypertension. Additionally, the study examines the effects of blood pressure reduction on the levels of high sensitivity hsCRP. Although the main goal is to determine the overall effect of blood pressure reduction on hsCRP levels, analysis will also evaluate whether an aggressive antihypertensive regimen is more effective than a moderate one in reducing hsCRP levels.

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, Valsartan HCT

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Stage 2 hypertension as defined by the mean of three (3) repeated seated BP measurements of: SBP of 160 to 185 mmHg, inclusive and/or DBP of 100 to 109 mmHg, inclusive.
2. Patients must have documentation of serum creatinine equal or \<2.0 mg/dL, serum potassium equal or \>3.5 and equal or \<5.5 mmol/L, and serum AST or ALT \<2xULN obtained within 3 months prior to Visit 1.
3. Patients must have documentation of HbA1C equal or \<11.0 % obtained within 1 month prior to Visit 1.

Exclusion Criteria

1. History of secondary hypertension.
2. Pharmacologic antihypertensive therapy with ACE inhibitors, angiotensin receptor blockers, or aldosterone blockers within 3 months prior to Visit 1, or with thiazide diuretics within 1 month prior to Visit 1. The use of other classes of agents which lower BP but are being used for other therapy or for HTN, are allowed as long as these agents are started at least 3 months prior to randomization, are not initiated after enrollment and doses remain unchanged during the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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

References

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Everett BM, Glynn RJ, Danielson E, Ridker PM; Val-MARC Investigators. Combination therapy versus monotherapy as initial treatment for stage 2 hypertension: a prespecified subgroup analysis of a community-based, randomized, open-label trial. Clin Ther. 2008 Apr;30(4):661-72. doi: 10.1016/j.clinthera.2008.04.013.

Reference Type DERIVED
PMID: 18498915 (View on PubMed)

Other Identifiers

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CVAH631DUS02

Identifier Type: -

Identifier Source: org_study_id