8 Weeks Study to Evaluate the Efficacy and Safety of Valsartan in Combination With Aliskiren Compared to Valsartan Alone in Patients With Stage 2 Hypertension (VANTAGE)
March 31, 2011 updated by: Novartis
An 8-week Randomized, Double-Blind, Parallel Group, Multi-Center, Active Controlled Study to Evaluate the Efficacy and Safety of Valsartan Administered in Combination With Aliskiren (160/150 mg, 320/300 mg) Versus Valsartan Alone (160 mg, 320 mg) in Patients With Stage 2 Hypertension
To evaluate the efficacy and safety of the valsartan/aliskiren combination compared to valsartan alone in patients with Stage 2 hypertension.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
451
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New Jersey
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East Hanover, New Jersey, United States, 07936
- Sites in USA
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
- Men or women 18 years and older.
- Patients with Stage 2 systolic hypertension; defined as having a MSSBP ≥160 mmHg and <180 mmHg at Visit 5 (randomization).
Exclusion Criteria:
- Use of aliskiren or participation in a clinical trial that had aliskiren as treatment within 30 days of Visit 1.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>5 mIU/ml).
- Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation), hormonal contraception (implantable, patch, oral), and double-barrier methods. Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation.
- Severe hypertension (an office cuff MSDBP ≥110 mmHg and/or MSSBP ≥180 mmHg).
- Refractory hypertension, defined as unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90 mmHg).
- Patients treated with more than 3 antihypertensive medications (each component of a combination drug counts individually).
- History or evidence of a secondary form of hypertension.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Valsartan/aliskiren
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Valsartan/aliskiren (160/150mg) for 2 weeks followed by forced titration to valsartan/aliskiren (320/300mg) for the remaining 6 weeks
|
|
Active Comparator: Valsartan
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Valsartan (160mg) for 2 weeks followed by forced titration to Valsartan (320mg) for the remaining 6 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8
Time Frame: Baseline to Week 8
|
To compare the change from baseline in MSSBP after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.
|
Baseline to Week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8
Time Frame: Baseline to Week 8
|
To compare the change in MSDBP after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan (160 mg, 320 mg) treatment regimen in patients with Stage 2 Hypertension.
|
Baseline to Week 8
|
|
Percentage of Patients Achieving Blood Pressure Control (Defined as Patients Achieving a MSSBP <140 mmHg and MSDBP <90 mmHg) at Week 8
Time Frame: At Week 8
|
To evaluate the percentage of patients achieving blood pressure control (defined as patients achieving a MSSBP <140 mmHg and MSDBP <90 mmHg) at week 8 following treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.
|
At Week 8
|
|
Percentage of Responders (Defined as Patients With MSSBP <140 mmHg or a Decrease From Baseline ≥20 mmHg) at Week 8
Time Frame: At Week 8
|
To compare the percentage of responders (defined as patients with MSSBP <140 mmHg or a decrease from baseline ≥20 mmHg) at week 8 following treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.
|
At Week 8
|
|
Mean Change From Baseline in Plasma Renin Activity (PRA) at Week 8
Time Frame: Baseline to Week 8
|
To assess the change from baseline in PRA after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.
|
Baseline to Week 8
|
|
Mean Change From Baseline in Plasma Renin Concentration (PRC) at Week 8
Time Frame: Baseline to Week 8
|
To assess the change from baseline in PRC after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.
|
Baseline to Week 8
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Completers Analysis for Change From Baseline in MSSBP at Week 8
Time Frame: Baseline to week 8
|
To evaluate the change from baseline in MSSBP (mmHg) at Week 8; primary efficacy variable at primary time point in ITT population - patients who completed the double-blind treatment period.
|
Baseline to week 8
|
|
Longitudinal Repeated Measure Analysis for Change in MSSBP From Baseline Through Week 8
Time Frame: Baseline through week 8
|
To evaluate the change from baseline in MSSBP (mmHg) after 8 weeks; primary efficacy variable (ITT population) using Longitudinal analysis (A repeated measures analysis where assessments over time are considered , as opposed to looking at a single point in time.)
|
Baseline through week 8
|
|
Change From Baseline in Mean Ambulatory Systolic Blood Pressure (MASBP).
Time Frame: Baseline to week 8
|
To evaluate 24-hour ambulatory systolic blood pressure measurements in a subset of patients after 8 weeks of treatment with the combination of valsartan and aliskiren versus valsartan monotherapy in patients with stage 2 hypertension.
|
Baseline to week 8
|
|
Change From Baseline in Mean Ambulatory Diastolic Blood Pressure (MADBP)
Time Frame: Baseline to week 8
|
To evaluate 24-hour ambulatory diastolic blood pressure measurements in a subset of patients after 8 weeks of treatment with the combination of valsartan and aliskiren versus valsartan monotherapy in patients with stage 2 hypertension.
|
Baseline to week 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
December 16, 2008
First Submitted That Met QC Criteria
December 16, 2008
First Posted (Estimate)
December 17, 2008
Study Record Updates
Last Update Posted (Estimate)
May 2, 2011
Last Update Submitted That Met QC Criteria
March 31, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSPV100AUS01
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