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 HCTZChange 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
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