Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Therapy in Patients With Hypertension
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
1 other identifier
interventional
648
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 19, 2006
CompletedFirst Posted
Study publicly available on registry
January 23, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2006
CompletedNovember 9, 2010
March 1, 2008
8 months
January 19, 2006
November 5, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from baseline systolic blood pressure after 4 weeks
Change from baseline systolic blood pressure after 2 and 6 weeks
Secondary Outcomes (4)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (1)
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936, United States
Related Publications (1)
Zappe DH, Palmer BF, Calhoun DA, Purkayastha D, Samuel R, Jamerson KA. Effectiveness of initiating treatment with valsartan/hydrochlorothiazide in patients with stage-1 or stage-2 hypertension. J Hum Hypertens. 2010 Jul;24(7):483-91. doi: 10.1038/jhh.2009.90. Epub 2009 Dec 10.
PMID: 20010618DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 19, 2006
First Posted
January 23, 2006
Study Start
December 1, 2005
Primary Completion
August 1, 2006
Last Updated
November 9, 2010
Record last verified: 2008-03