Valsartan/Hydrochlorothiazide Combination in the Treatment of Severe Hypertension
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
1 other identifier
interventional
607
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hypertension
Started Nov 2005
Shorter than P25 for phase_3 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 4, 2006
CompletedFirst Posted
Study publicly available on registry
January 9, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedNovember 8, 2011
November 1, 2011
8 months
January 4, 2006
November 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood pressure less than 140/90 mmHg after 4 weeks
Secondary Outcomes (5)
Blood pressure less than 140/90 mmHg after 6 weeks
Diastolic blood pressure less than 90 mmHg after 4 and 6 weeks
Systolic blood pressure less than 140 mmHg after 4 and 6 weeks
Change from baseline in systolic and diastolic blood pressure after 4 and 6 weeks
Adverse events and serious adverse events at each study visit for 6 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosed severe hypertension
You may not qualify if:
- 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
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)
Calhoun DA, Glazer RD, Pettyjohn FS, Coenen PD, Zhao Y, Grosso A. Efficacy and tolerability of combination therapy with valsartan/hydrochlorothiazide in the initial treatment of severe hypertension. Curr Med Res Opin. 2008 Aug;24(8):2303-11. doi: 10.1185/03007990802271946. Epub 2008 Jun 28.
PMID: 18593517DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2006
First Posted
January 9, 2006
Study Start
November 1, 2005
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
November 8, 2011
Record last verified: 2011-11