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)

Novartis

Status and phase

Completed

Phase 4

Conditions

Stage 2 Hypertension

Treatments

Drug: Valsartan

Drug: Valsartan/aliskiren

Study type

Interventional

Funder types

Industry

Identifiers

NCT00809926

CSPV100AUS01

Details and patient eligibility

About

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

Enrollment

451 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.