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: Stage 2 Hypertension
MeSH terms: Hypertension
Intervention: Valsartan/aliskiren; Valsartan
Intervention description: Valsartan/aliskiren (160/150mg) for 2 weeks followed by forced titration to valsartan/aliskiren (320/300mg) for the remaining 6 weeks; Valsartan (160mg) for 2 weeks followed by forced titration to Valsartan (320mg) for the remaining 6 weeks
Intervention MeSH terms: Valsartan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 451.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hypertension, aliskiren and valsartan

Summary:

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

Eligibility 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.