Aliskiren and the Calcium Channel Blocker Amlodipine Combination as an Initial Treatment Strategy for Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00797862
• Date of registration: 24/11/2008
• Primary sponsor: Novartis
• Public title: Aliskiren and the Calcium Channel Blocker Amlodipine Combination as an Initial Treatment Strategy for Hypertension ACCELERATE
• Scientific 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
• Date of first enrolment: November 2008
• Target sample size: 1254
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00797862
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Countries of recruitment

Canada, Costa Rica, France, Germany, Greece, Guatemala, Peru, South Africa, Switzerland, United Kingdom, Venezuela

Contacts

• Name: Novartis
• Affiliation: Novartis

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hypertension

Intervention(s)

Drug: Aliskiren

Drug: Amlodipine

Drug: hydrochlorothiazide

Primary Outcome(s)

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 24 [Time Frame: Baseline to 24 weeks]

Overall Mean Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Over 8, 16 and 24 Weeks [Time Frame: Baseline, 8 weeks, 16 weeks, and 24 weeks]

Secondary Outcome(s)

Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 24 [Time Frame: Baseline to 24 weeks]

Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 32 [Time Frame: Baseline to 32 weeks]

Overall Mean Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Over 8, 16, and 24 Weeks [Time Frame: Baseline, 8 weeks, 16 weeks and 24 weeks]

Percentage of Participants Achieving Overall Blood Pressure Control at 8, 16, 24 and 32 Weeks Endpoints [Time Frame: Baseline to week 8, 16, 24 and 32 endpoints]

Secondary ID(s)

CSPA100A2307

Source(s) of Monetary Support

Please refer to primary and secondary sponsors