Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

East Hanover, New Jersey 07936


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


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.



Primary Contact:

Study Chair

Backup Contact:


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

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.