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

Completed · Phase 4

Conditions studied: Stage 2 Hypertension

In brief

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

Key facts

Study ID

NCT00809926

Run by

Novartis

People needed

451

Starts

2009-01-01

Expected to finish

2009-07-01

Last updated by the study team

2011-05-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Sites in USA — East Hanover, New Jersey, United States

Full record on ClinicalTrials.gov

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