Expired Study
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East Hanover, New Jersey 07936


Purpose:

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


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.


NCT ID:

NCT00809926


Primary Contact:

Study Chair
Novartis
Novartis


Backup Contact:

N/A


Location Contact:

East Hanover, New Jersey 07936
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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