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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00425997
First received: January 23, 2007
Last updated: June 7, 2011
Last verified: June 2011
  Purpose

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)


Condition Intervention Phase
Hypertension
Drug: Valsartan/HCTZ
Drug: amlodipine
Drug: HCTZ
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • -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 Measures:
  • 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

Estimated Enrollment: 480
Study Start Date: December 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425997

Locations
United States, New Jersey
Sites in USA
East Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharmaceuticals Sponsor GmbH
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study director, Novartis
ClinicalTrials.gov Identifier: NCT00425997     History of Changes
Other Study ID Numbers: CVAH631BUS07
Study First Received: January 23, 2007
Last Updated: June 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Hypertension, valsartan/HCTZ, amlodipine and HCTZ

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Valsartan
Amlodipine
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Calcium Channel Blockers
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on July 22, 2014