COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Valsartan/Hydrochlorothiazide Combination in the Treatment of Severe Hypertension

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. Identifier: NCT00273299
Recruitment Status : Completed
First Posted : January 9, 2006
Last Update Posted : November 8, 2011
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to assess the potential of using valsartan/HCTZ as initial therapy in patients with severe hypertension compared to valsartan alone as initial therapy, and to determine whether a greater proportion of patients achieve blood pressure control with the combination compared to the monotherapy without producing an unacceptable adverse event profile.

Condition or disease Intervention/treatment Phase
Hypertension Drug: valsartan plus hydrochlorothiazide Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 607 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A 6-Week Study to Evaluate the Combination of Valsartan/HCTZ (160/12.5mg With Forced Titration to Maximum Dose of 320/25mg) Compared to Valsartan Monotherapy (160mg With Forced Titration to 320mg) as Initial Therapy in Patients With Severe Hypertension
Study Start Date : November 2005
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Blood pressure less than 140/90 mmHg after 4 weeks

Secondary Outcome Measures :
  1. Blood pressure less than 140/90 mmHg after 6 weeks
  2. Diastolic blood pressure less than 90 mmHg after 4 and 6 weeks
  3. Systolic blood pressure less than 140 mmHg after 4 and 6 weeks
  4. Change from baseline in systolic and diastolic blood pressure after 4 and 6 weeks
  5. Adverse events and serious adverse events at each study visit for 6 weeks

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.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Diagnosed severe hypertension

Exclusion Criteria:

  • Inability to discontinue all prior antihypertensive medications
  • Heart failure of any kind
  • History of stroke, transient ischemic attack, myocardial infarction, chest pain, abnormal heart rhythm Liver, kidney, or pancreas disease
  • Diabetes with poor glucose control
  • Allergy to certain medications used to treat high blood pressure

Other protocol-defined exclusion criteria may apply.

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 identifier (NCT number): NCT00273299

Layout table for location information
United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Layout table for investigator information
Study Director: Novartis Pharmaceuticals
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Novartis Identifier: NCT00273299    
Other Study ID Numbers: CVAH631D2301
First Posted: January 9, 2006    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: November 2011
Keywords provided by Novartis:
high blood pressure
severe hypertension
Additional relevant MeSH terms:
Layout table for MeSH terms
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators