Phase 4
N=451
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
Stage 2 Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00809926 ↗Enrolled (actual)
451
Serious AEs
1.8%
Results posted
May 2011
Primary outcome: Primary: Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 — 164.8; 166.2; 142.3; 145.6 mm Hg — p=0.295
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Valsartan/aliskiren (Drug); Valsartan (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 |
164.8; 166.2; 142.3; 145.6; -22.5; -20.6 | 0.295 |
| SECONDARY Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8 |
93.9; 94.8; 85.7; 86.4; -8.2; -8.3 | 0.790 |
| SECONDARY Percentage of Patients Achieving Blood Pressure Control (Defined as Patients Achieving a MSSBP <140 mmHg and MSDBP <90 mmHg) at Week 8 |
44.3; 36.2 | 0.101 |
| SECONDARY Percentage of Responders (Defined as Patients With MSSBP <140 mmHg or a Decrease From Baseline ≥20 mmHg) at Week 8 |
64.7; 53.1 | 0.018 sig |
| SECONDARY Mean Change From Baseline in Plasma Renin Activity (PRA) at Week 8 |
0.992; 0.831; 0.436; 2.450; -0.540; 1.577 | — |
| SECONDARY Mean Change From Baseline in Plasma Renin Concentration (PRC) at Week 8 |
8.286; 8.065; 142.833; 20.089; 135.515; 11.988 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT00809926). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.