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

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

Purpose

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

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Valsartan Aliskiren

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Novartis:

Primary Outcome Measures:

Change in mean sitting systolic blood pressure (MSSBP) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in mean sitting diastolic blood pressure (MSDBP) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Percentage of patients achieving blood pressure control (defined as patients achieving a MSSBP <140 mmHg and MSDBP <90 mmHg) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Percentage of responders (defined as patients with MSSBP <140 mmHg or a decrease from baseline ≥20 mmHg) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline in plasma renin activity (PRA) and plasma renin concentration (PRC) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Safety and tolerability of the valsartan and aliskiren combination (160/150 mg, 320/300 mg) compared to valsartan monotherapy (160 mg, 320 mg) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	762
Study Start Date:	January 2009
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Valsartan/aliskiren (160/150mg) for 2 weeks Valsartan/aliskiren (320/300mg) for another 6 weeks	Drug: Valsartan/aliskiren Valsartan/aliskiren (160/150mg) for 2 weeks followed by forced titration to valsartan/aliskiren (320/300mg)
2: Active Comparator Valsartan (160mg) 2 weeks - Valsartan (320mg) 6 weeks	Drug: Valsartan Valsartan (160mg 2weeks- Valsartan (320mg) 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 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 a 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

Contacts

Contact: Novartis

862-778-8300

Locations

United States, New Jersey
Investigative Site	Recruiting
East Hanover, New Jersey, United States, 07936
Contact: Novartis 862-778-8300

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CSPV100AUS01
Study First Received:	December 16, 2008
Last Updated:	April 20, 2009
ClinicalTrials.gov Identifier:	NCT00809926 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Hypertension, aliskiren and valsartan

Study placed in the following topic categories:

Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Valsartan
Hypertension

Additional relevant MeSH terms:

Therapeutic Uses
Vascular Diseases
Cardiovascular Diseases
Cardiovascular Agents

Antihypertensive Agents
Pharmacologic Actions
Valsartan
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009