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

Condition(s) targeted: Stage 2 Hypertension

Intervention: Valsartan/aliskiren (Drug); Valsartan (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Study Chair, Affiliation: Novartis

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

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

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

Primary outcome: Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8

Secondary outcome:

Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8

Percentage of Patients Achieving Blood Pressure Control (Defined as Patients Achieving a MSSBP <140 mmHg and MSDBP <90 mmHg) at Week 8

Percentage of Responders (Defined as Patients With MSSBP <140 mmHg or a Decrease From Baseline ≥20 mmHg) at Week 8

Mean Change From Baseline in Plasma Renin Activity (PRA) at Week 8

Mean Change From Baseline in Plasma Renin Concentration (PRC) at Week 8

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Sites in USA, East Hanover, New Jersey 07936, United States

Starting date: January 2009
Last updated: March 31, 2011