Clinical trial NCT00666536: The Effects of Moderate vs. Aggressive Treatment With Valsartan + Amlodipine on Patients With Hypertension Uncontrolled by Angiotensin-Receptor Blocker (Herein, ARB) Monotherapy
Official title: A Multicenter, Randomized, Double Blind, Parallel Design Trial to Evaluate the Blood Pressure Lowering Efficacy Comparing Moderate Versus Aggressive Treatment Regimen of Valsartan + Amlodipine in Patients Uncontrolled on ARB Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Hypertension
adults
Valsartan + Amlodipine
Angiotensin Receptor Blockers
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-04-25
Enrollment: 728
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: 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)

Primary outcomes:
measure: Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP)
timeFrame: Baseline and Week 4
Secondary outcomes:
measure: Percentage of Patients Achieving the Blood Pressure (BP) Goal of < 140/90 mmHg at Weeks 2,4,8 and 12
timeFrame: Weeks 2, 4, 8 and 12
measure: Change From Baseline to Week 4 in Mean Sitting Diastolic Blood Pressure (MSDBP)
timeFrame: Baseline and Week 4
measure: Change From Baseline to Weeks 2, 8 and 12 in MSSBP
timeFrame: Baseline and Weeks 2, 8 and 12
measure: Change From Baseline to Weeks 2, 8 and 12 in MSDBP
timeFrame: Baseline and Weeks 2, 8 and 12
measure: Percentage of Patients Achieving BP Goal of MSSBP < 140mmHg at Weeks 2, 4, 8 and 12
timeFrame: Weeks 2, 4, 8 and 12
Other outcomes:
Locations:
city: Metairie
country: United States
facility: Egan Healthcare
state: Louisiana
Study officials:
affiliation: University of Alabama at Birmingham
name: Suzanne Oparil, MD et al
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oparil S, Giles T, Ofili EO, Pitt B, Seifu Y, Hilkert R, Samuel R, Sowers JR. Moderate versus intensive treatment of hypertension with amlodipine/valsartan for patients uncontrolled on angiotensin receptor blocker monotherapy. J Hypertens. 2011 Jan;29(1):161-70. doi: 10.1097/HJH.0b013e32834000a7.
citation: Giles TD, Oparil S, Ofili EO, Pitt B, Purkayastha D, Hilkert R, Samuel R, Sowers JR. The role of ambulatory blood pressure monitoring compared with clinic and home blood pressure measures in evaluating moderate versus intensive treatment of hypertension with amlodipine/valsartan for patients uncontrolled on angiotensin receptor blocker monotherapy. Blood Press Monit. 2011 Apr;16(2):87-95. doi: 10.1097/MBP.0b013e328344c713.