We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00280540
First Posted: January 23, 2006
Last Update Posted: November 9, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  Purpose
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).

Condition Intervention Phase
Hypertension Drug: Valsartan/Hydrochlorothiazide Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A 6-week Treatment Regimen Study to Evaluate the Efficacy of Initial High Dose Valsartan Monotherapy (160 mg) or Combo Therapy (Valsartan + Hydrochlorothiazide, 160/12.5 mg) to Conventional Low-dose Valsartan Monotherapy (80 mg) in Managing Patients With Hypertension

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline systolic blood pressure after 4 weeks
  • Change from baseline systolic blood pressure after 2 and 6 weeks

Secondary Outcome Measures:
  • Time in weeks to achieve blood pressure less than 140/90 mmHg over 6 week period
  • Blood pressure less than 140/90 mmHg after 6 weeks
  • Change from baseline diastolic blood pressure after 6 weeks
  • Change from baseline in blood and urine markers after 6 weeks

Estimated Enrollment: 648
Study Start Date: December 2005
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

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.

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00280540


Locations
United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00280540     History of Changes
Other Study ID Numbers: CVAH631BUS05
First Submitted: January 19, 2006
First Posted: January 23, 2006
Last Update Posted: November 9, 2010
Last Verified: March 2008

Keywords provided by Novartis:
Hypertension
High blood pressure
Blood pressure control
Blood pressure reduction
Valsartan

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