Phase 4
N=488
Valsartan/Amlodipine As Compared to Losartan Treatment in Stage 2 Systolic Hypertension
Stage 2 Systolic Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00931710 ↗Enrolled (actual)
488
Serious AEs
0.6%
Results posted
Feb 2011
Primary outcome: Primary: Change in Mean Sitting Systolic Blood Pressure After 6 Weeks — 166.8; 168.5; 135.5; 142.5 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- valsartan, amlodipine, HCTZ (Drug); Losartan, HCTZ followed by valsartan, amlodipine, HCTZ (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Sitting Systolic Blood Pressure After 6 Weeks |
166.8; 168.5; 135.5; 142.5; -31.3; -26.0 | — |
| SECONDARY Change in Mean Sitting Diastolic Blood Pressure After 6 Weeks |
98.6; 97.6; 85.1; 88.5; -13.6; -9.1 | — |
| SECONDARY Cumulative Percentage of Patients Achieving Blood Pressure Control |
30.5; 15.3; 61.5; 47.1 | — |
| SECONDARY Cumulative Percentage of Treatment Responders |
65.3; 34.3; 87.0; 71.5 | — |
| SECONDARY Change in Mean Sitting Systolic and Diastolic Blood Pressure After 12 Weeks |
166.8; 168.5; 130.8; 134.3; -36.0; -34.2 | — |
| SECONDARY Cumulative Percentage of Patients With Incidence of Peripheral Edema Before or at the Corresponding Visit |
0.8; 0.8; 0.8; 0.8; 1.3; 0.8 | — |
Summary
This study will compare the antihypertensive efficacy and safety of a valsartan/amlodipine-based treatment with a losartan-based treatment in patients with Stage 2 systolic hypertension (high blood pressure, mean systolic blood pressure greater than 160 and less than 200 mmHg).
Eligibility Criteria
Inclusion Criteria
- Male or female outpatient of 18 years of age or greater
- Stage 2 systolic hypertension defined as office Mean Sitting Systolic blood pressure (MSSBP) greater than or equal to 160 and 200 and/or mean sitting diastolic blood pressure (MSDBP) greater than or equal to 110 mmHg at Visit 1.
- Use of four (4) or more antihypertensive medications within 30 days of Visit 1.
- Refractory hypertension, defined as blood pressure >140/90 mmHg while taking three (3) drugs at the maximum dose of each drug, one of which must be a diuretic. (Therapy with a fixed-dose combination of two active medications represents two drugs).
- Inability to safely discontinue all antihypertensive medications for 1-2 weeks prior to randomization.
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00931710). 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.