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
Information source: Novartis
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stage 2 Hypertension
Intervention: Valsartan/aliskiren (Drug); Valsartan (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis, Study Chair, Affiliation: Novartis
Overall contact:
Novartis, Phone: 862-778-8300
Summary
Evaluate the efficacy and safety of the valsartan/aliskiren combination compared to valsartan
alone in patients with Stage 2 hypertension.
Clinical Details
Official title: An 8-Week Randomized, Double-Blind, Parallel Group, Multi-Center, Active Controlled Study to Evaluate the Efficacy and Safety of Valsartan Administered in Combination With Aliskiren (160/150 mg, 320/300 mg) Versus Valsartan Alone (160 mg, 320 mg) in Patients With Stage 2 Hypertension
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change in mean sitting systolic blood pressure (MSSBP)
Secondary outcome: Change in mean sitting diastolic blood pressure (MSDBP)Percentage of patients achieving blood pressure control (defined as patients achieving a MSSBP <140 mmHg and MSDBP <90 mmHg) Percentage of responders (defined as patients with MSSBP <140 mmHg or a decrease from baseline ≥20 mmHg) Change from baseline in plasma renin activity (PRA) and plasma renin concentration (PRC) Safety and tolerability of the valsartan and aliskiren combination (160/150 mg, 320/300 mg) compared to valsartan monotherapy (160 mg, 320 mg)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Novartis, Phone: 862-778-8300
Investigative Site, East Hanover, New Jersey 07936, United States
Additional Information
Starting date: January 2009
Last updated: December 16, 2008
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