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 - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00809926

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 IV

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:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Valsartan Aliskiren

U.S. FDA Resources

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

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

More Information

No publications provided

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
Vascular Diseases
Cardiovascular Diseases
Valsartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012