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Efficacy of Valsartan/Hydrochlorothiazide Versus Amlodipine and Hydrochlorothiazide in Patients Hypertension

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Valsartan/HCTZ (Drug); amlodipine (Drug); HCTZ (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Chair, Affiliation: Sponsor GmbH

Summary

This study will evaluate the efficacy of valsartan/hydrochlorothiazide versus amlodipine and hydrochlorothiazide in patients with Stage 2 hypertension using 24-hr ambulatory blood pressure monitoring (ABPM)

Clinical Details

Official title: A 10-week Multicenter,Forced-titration Study Using 24-hr ABPM to Evaluate the Efficacy of Valsartan/Hydrochlorothiazide (HCTZ) Treatment Regimen vs Conventional Treatment Regimen With Amlodipine and Hydrochlorothiazide (HCTZ) in Patients With Stage 2 Hypertension

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: -Change from baseline in mean 24-hr ambulatory systolic blood pressure (BP) after 10 weeks of treatment of valsartan/HCTZ versus amlodipine and HCTZ

Secondary outcome:

change from baseline in mean 24-hr ambulatory diastolic BP and pulse pressure after 10 weeks of treatment of valsartan/HCTZ versus amlodipine and HCTZ

Change from baseline in mean seated systolic and diastolic BP after 10 weeks of treatment of valsartan/HCTZ versus amlodipine and HCTZ

Compare the proportion of patients achieving blood pressure goal and tolerability after 10 weeks of treatment of valsartan/HCTZ versus amlodipine and HCTZ

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female patients 18 years of age or older

- Diagnosed of having hypertension, defined as a mean seated systolic BP ≥160 mmHg

(Stage 2 hypertension) Exclusion Criteria:

- Symptomatic or severe hypertension

- Patients treated with more than 2 antihypertensive medications

- Clinically known or suspected history of secondary hypertension

- Myocardial infarction, stroke, transient ischemic attack, cardiovascular

revascularization/angioplasty in last 6 months

- Diagnosis of heart failure (NYHA Class II-IV)

- Chronic renal or severe hepatic disease

Locations and Contacts

Sites in USA, East Hanover, New Jersey 07936, United States
Additional Information

Starting date: December 2006
Last updated: June 7, 2011

Page last updated: August 23, 2015

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