Clinical trial NCT00809926: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stage 2 Hypertension
Keywords: Hypertension, aliskiren and valsartan
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-12-17
Enrollment: 451
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 systolic 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 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.

Primary outcomes:
measure: Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8
timeFrame: Baseline to Week 8
Secondary outcomes:
measure: Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8
timeFrame: Baseline to Week 8
measure: Percentage of Patients Achieving Blood Pressure Control (Defined as Patients Achieving a MSSBP <140 mmHg and MSDBP <90 mmHg) at Week 8
timeFrame: At Week 8
measure: Percentage of Responders (Defined as Patients With MSSBP <140 mmHg or a Decrease From Baseline ≥20 mmHg) at Week 8
timeFrame: At Week 8
measure: Mean Change From Baseline in Plasma Renin Activity (PRA) at Week 8
timeFrame: Baseline to Week 8
measure: Mean Change From Baseline in Plasma Renin Concentration (PRC) at Week 8
timeFrame: Baseline to Week 8
Other outcomes:
measure: Completers Analysis for Change From Baseline in MSSBP at Week 8
timeFrame: Baseline to week 8
measure: Longitudinal Repeated Measure Analysis for Change in MSSBP From Baseline Through Week 8
timeFrame: Baseline through week 8
measure: Change From Baseline in Mean Ambulatory Systolic Blood Pressure (MASBP).
timeFrame: Baseline to week 8
measure: Change From Baseline in Mean Ambulatory Diastolic Blood Pressure (MADBP)
timeFrame: Baseline to week 8
Locations:
city: East Hanover
country: United States
facility: Sites in USA
state: New Jersey
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References:
citation: Flack JM, Yadao AM, Purkayastha D, Samuel R, White WB. Comparison of the effects of aliskiren/valsartan in combination versus valsartan alone in patients with stage 2 hypertension. J Am Soc Hypertens. 2012 Mar-Apr;6(2):142-51. doi: 10.1016/j.jash.2011.11.004. Epub 2012 Feb 9.