Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Long Term Study of VAH631 in Patients With Essential Hypertension (Extension From B1303 Study)

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.
 
ClinicalTrials.gov Identifier: NCT00338936
Recruitment Status : Completed
First Posted : June 20, 2006
Last Update Posted : November 8, 2011
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study is designed to provide long-term safety and efficacy data for the combination doses of VAH (VAL/ HCTZ) 40/6.25mg and 80/12.5mg in essential hypertensive patients. The 350 patients (approximately) who have successfully finished the core trial CVAH631B1303 and signed consent for the extension will be enrolled into this study.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Valsartan + Hydrochlorothiazide Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 362 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 52-week Extension to the Factorial Study to Evaluate the Efficacy and Safety of VAH631 (Valsartan and Hydrochlorothiazide Combined) and Alone in Essential Hypertensive Patients - Long Term Study of VAH631 in Patients With Essential Hypertension (Extension From B1303 Study) -
Study Start Date : May 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Assessment of safety through reporting of adverse events, serious adverse events and deaths over 52 weeks.

Secondary Outcome Measures :
  1. Change from baseline in average sitting diastolic blood pressure after 52 weeks
  2. Change from baseline in average sitting systolic blood pressure after 52 weeks
  3. Change from baseline in average standing diastolic blood pressure after 52 weeks
  4. Change from baseline in average standing systolic blood pressure after 52 weeks
  5. Laboratory abnormalities after 52 weeks

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Patients who successfully complete the core study (Protocol 1303)
  • Outpatients

Exclusion Criteria:

  • Presence of crucial protocol violation in Protocol 1303
  • Patients who experienced any adverse events considered serious and drug related in Protocol 1303.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00338936


Sponsors and Collaborators
Novartis
Investigators
Layout table for investigator information
Study Director: Novartis Pharma Ag Novartis Pharmaceuticals
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00338936    
Other Study ID Numbers: CVAH631B1303E1
First Posted: June 20, 2006    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: November 2011
Keywords provided by Novartis:
Hypertension
Valsartan
Hydrochlorothiazide
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Essential 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