Status:
COMPLETED
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
Lead Sponsor:
Novartis
Conditions:
Stage 2 Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
451 Patients enrolled
Trial Details
Trial ID
NCT00809926
Start Date
January 1 2009
End Date
July 1 2009
Last Update
May 2 2011
Active Locations (1)
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1
Sites in USA
East Hanover, New Jersey, United States, 07936