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)

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00809926
First received: December 16, 2008
Last updated: March 31, 2011
Last verified: March 2011
  Purpose

To evaluate the efficacy and safety of the valsartan/aliskiren combination compared to valsartan alone in patients with Stage 2 hypertension.


Condition Intervention Phase
Stage 2 Hypertension
Drug: Valsartan/aliskiren
Drug: Valsartan
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8 [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in Plasma Renin Activity (PRA) at Week 8 [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in Plasma Renin Concentration (PRC) at Week 8 [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
    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.


Enrollment: 451
Study Start Date: January 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Valsartan/aliskiren Drug: Valsartan/aliskiren
Valsartan/aliskiren (160/150mg) for 2 weeks followed by forced titration to valsartan/aliskiren (320/300mg) for the remaining 6 weeks
Active Comparator: Valsartan Drug: Valsartan
Valsartan (160mg) for 2 weeks followed by forced titration to Valsartan (320mg) for the remaining 6 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809926

Locations
United States, New Jersey
Sites in USA
East Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00809926     History of Changes
Other Study ID Numbers: CSPV100AUS01
Study First Received: December 16, 2008
Results First Received: December 10, 2010
Last Updated: March 31, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Hypertension, aliskiren and valsartan

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Valsartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014