Phase 4 N=728 Randomized Triple-blind Treatment

The Effects of Moderate vs. Aggressive Treatment With Valsartan + Amlodipine on Patients With Hypertension Uncontrolled by Angiotensin-Receptor Blocker (Herein, ARB) Monotherapy

Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT00666536 ↗

Enrolled (actual)

728

Serious AEs

1.9%

Results posted

Dec 2010

Primary outcome: Primary: Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP) — 163.9; 163.3; 140.9; 144.4 mmHg

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: valsartan and amlodipine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis
Primary completion: Jan 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP)	163.9; 163.3; 140.9; 144.4; -23.0; -18.9	—
SECONDARY Percentage of Patients Achieving the Blood Pressure (BP) Goal of < 140/90 mmHg at Weeks 2,4,8 and 12	25.1; 25.8; 43.7; 31.1; 61.7; 46.2	—
SECONDARY Change From Baseline to Week 4 in Mean Sitting Diastolic Blood Pressure (MSDBP)	95.5; 95.0; 84.8; 86.2; -10.7; -8.8	—
SECONDARY Change From Baseline to Weeks 2, 8 and 12 in MSSBP	163.9; 163.3; 147.0; 146.0; -16.9; -17.3	—
SECONDARY Change From Baseline to Weeks 2, 8 and 12 in MSDBP	95.5; 95.0; 88.2; 87.1; -7.3; -7.9	—
SECONDARY Percentage of Patients Achieving BP Goal of MSSBP < 140mmHg at Weeks 2, 4, 8 and 12	31.1; 32.5; 49.2; 37.5; 66.1; 49.6	—

Summary

The purpose of this trial is to compare blood pressure lowering efficacy of moderate Valsartan + Amlodipine treatment regimen (160 / 5 mg) with that of aggressive regimen (320 / 10 mg) in patients uncontrolled on ARB monotherapy, other than Valsartan

Eligibility Criteria

Inclusion Criteria

Male and female outpatients
18 Years of age or older
Mean Sitting Systolic Blood Pressure (the top number) greater than or equal to 150 mmHg and lower than 200 mmHg while on Angiotensin-Receptor Blocker monotherapy for a minimum period of 28 days prior to randomization

Exclusion Criteria

Mean Sitting Systolic Blood Pressure (the top number) greater than or equal to 200 mmHg and/or Mean Sitting Diastolic Blood Pressure greater than or equal to 120 mmHg
Transient ischemic attack (mini-stroke), myocardial infarction (heart attack), all types of revascularization procedures in the last 6 months
Treatment with valsartan or any combination antihypertensive treatment with 28 days prior to screening (Visit 1)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00666536). 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.