Clinical trial NCT00797862: Aliskiren and the Calcium Channel Blocker Amlodipine Combination as an Initial Treatment Strategy for Hypertension
Official title: A Randomized, 32 Week Double-blind, Parallel-group, Multicenter Study to Compare the Efficacy and Safety of Initiating Treatment With Combination (Aliskiren/Amlodipine) Therapy in Comparison With the Sequential add-on Treatment Strategies in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Aliskiren
Amlodipine
Hypertension
SPA1000
Norvasc
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-11-25
Enrollment: 1254
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will compare the safety and efficacy of initial combination treatment with aliskiren + amlodipine to sequential add-on treatment strategies with aliskiren or amlodipine in patients with hypertension.

Detailed description: This study was designed to evaluate if patients with hypertension treated early with a combination therapy would achieve better blood pressure (BP) control, than patients being treated with a classical sequential add-on therapy.

The study compared the effects of the two treatment strategies: Treatment initiation on a single compound, either with aliskiren or amlodipine, and then continuation with the combination of both versus treatment initiation with the combination of aliskiren/amlodipine and then continuation with the combination. The study also evaluated if the overall mean sitting systolic blood pressure (msSBP)-lowering effect during the study, as well as the change from baseline to study end in msSBP, are superior in the group having received combination therapy from the beginning.

The study further evaluated the BP-lowering efficacy and tolerability of both treatment strategies.

Eligibility criteria: Inclusion Criteria:

* Male or female outpatients ≥ 18 years of age
* Participants with essential hypertension:

  * Naive participants must have a mean sitting Systolic Blood Pressure (msSBP) ≥ 150 mmHg and \< 180 mmHg at Visit 1 and Visit 2. (Participants are considered 'naïve' if they have never been treated with any antihypertensive medication.)
  * All participants must have a msSBP ≥ 150 mmHg and \< 180 mmHg at Visit 2
* Written informed consent to participate in this study prior to any study procedures

Exclusion Criteria:

* Severe hypertension
* Pregnant or nursing (lactating) women
* Pre-menopausal women not taking accepted form of birth control
* Serum potassium ≥ 5.5 mEq/L (mmol/L) at Visit 1
* History of cardiovascular conditions
* Uncontrolled Type 1 or Type 2 diabetes mellitus
* Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with similar chemical structures

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Overall Mean Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Over 8, 16 and 24 Weeks
timeFrame: Baseline, 8 weeks, 16 weeks, and 24 weeks
measure: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 24
timeFrame: Baseline to 24 weeks
Secondary outcomes:
measure: Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 32
timeFrame: Baseline to 32 weeks
measure: Overall Mean Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Over 8, 16, and 24 Weeks
timeFrame: Baseline, 8 weeks, 16 weeks and 24 weeks
measure: Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 24
timeFrame: Baseline to 24 weeks
measure: Percentage of Participants Achieving Overall Blood Pressure Control at 8, 16, 24 and 32 Weeks Endpoints
timeFrame: Baseline to week 8, 16, 24 and 32 endpoints
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Investigative Site
city: San Jose
country: Costa Rica
facility: Investigative Site
city: Paris
country: France
facility: Investigative Site
city: Bonn
country: Germany
facility: Investigative Site
city: Athens
country: Greece
facility: Investigative Site
city: Guatemala city
country: Guatemala
facility: Investigative Site
city: Cape Town
country: South Africa
facility: Investigative Site
city: Basel
country: Switzerland
facility: Investigative Site
city: London
country: United Kingdom
facility: Investigative Site
city: Caracas
country: Venezuela
facility: Investigative Site
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References:
citation: Brown MJ, Williams B, Morant SV, Webb DJ, Caulfield MJ, Cruickshank JK, Ford I, McInnes G, Sever P, Salsbury J, Mackenzie IS, Padmanabhan S, MacDonald TM; British Hypertension Society's Prevention and Treatment of Hypertension with Algorithm-based Therapy (PATHWAY) Studies Group. Effect of amiloride, or amiloride plus hydrochlorothiazide, versus hydrochlorothiazide on glucose tolerance and blood pressure (PATHWAY-3): a parallel-group, double-blind randomised phase 4 trial. Lancet Diabetes Endocrinol. 2016 Feb;4(2):136-47. doi: 10.1016/S2213-8587(15)00377-0. Epub 2015 Oct 18.
citation: Brown MJ, McInnes GT, Papst CC, Zhang J, MacDonald TM. Aliskiren and the calcium channel blocker amlodipine combination as an initial treatment strategy for hypertension control (ACCELERATE): a randomised, parallel-group trial. Lancet. 2011 Jan 22;377(9762):312-20. doi: 10.1016/S0140-6736(10)62003-X. Epub 2011 Jan 12.