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

Hypertension Clinical Trial

— ACCELERATE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00797862
• Other study ID #: CSPA100A2307
• Status: Completed
• Phase: Phase 3
• First received: November 24, 2008
• Last updated: October 7, 2011
• Start date: November 2008
• Est. completion date: November 2010

Study information

• Verified date: June 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCosta Rica: Ministry of Health Costa RicaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesGuatemala: Ministry of Public Health and Social AssistanceGreece: National Organization of MedicinesSouth Africa: Medicines Control CouncilSwitzerland: SwissmedicUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyVenezuela: Ministry of Health and Social Development
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1254
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Amlodipine
Amlodipine (5 mg and 10 mg) was provided as capsules taken orally once daily.
• hydrochlorothiazide
Hydrochlorothiazide 12.5 mg capsules were taken orally once daily
• Aliskiren
Aliskiren 150 mg and aliskiren 300 mg were provided as film-coated tablets, taken orally once daily.

Locations

Country	Name	City	State
Canada	Investigative Site	Toronto
Costa Rica	Investigative Site	San Jose
France	Investigative Site	Paris
Germany	Investigative Site	Bonn
Greece	Investigative Site	Athens
Guatemala	Investigative Site	Guatemala city
South Africa	Investigative Site	Cape Town
Switzerland	Investigative Site	Basel
United Kingdom	Investigative Site	London
Venezuela	Investigative Site	Caracas

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Mean Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Over 8, 16 and 24 Weeks	Systolic Blood Pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and over 8, 16 and 24 weeks of study treatment. The overall mean change in msSBP from baseline was estimated over three time points: Week 8, Week 16, and Week 24. Analysis used a repeated measures Analysis of Covariance (ANCOVA) model with treatment, visit, and region as factors, treatment by visit interaction and baseline msSBP as a covariate.	Baseline, 8 weeks, 16 weeks, and 24 weeks	No
Primary	Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 24	Systolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 24 weeks of study treatment. Analysis used a repeated measures ANCOVA model with treatment, visit and region as factors, treatment by visit interaction and baseline msSBP as a covariate.	Baseline to 24 weeks	No
Secondary	Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 32	Diastolic Blood Pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 32 weeks of study treatment. Change at Week 32 used a separate repeated measures ANCOVA model containing Week 8, 16, 24 and 32 data. Treatment, visit and region were factors in the model, treatment by visit interaction and baseline msDBP a covariate.	Baseline to 32 weeks	No
Secondary	Overall Mean Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Over 8, 16, and 24 Weeks	Diastolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and over 8, 16 and 24 weeks of study treatment. The overall mean change in msDBP from baseline was estimated over three time points: Week 8, Week 16, and Week 24. Analysis used a repeated measures ANCOVA model with treatment, visit and regions as factors, treatment by visit interaction and baseline msDBP as a covariate.	Baseline, 8 weeks, 16 weeks and 24 weeks	No
Secondary	Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 24	Diastolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 24 weeks of study treatment. Analysis used a repeated measures ANCOVA model with treatment, visit and region, as factors, treatment by visit interaction and baseline msDBP as a covariate.	Baseline to 24 weeks	No
Secondary	Percentage of Participants Achieving Overall Blood Pressure Control at 8, 16, 24 and 32 Weeks Endpoints	Systolic & Diastolic Blood Pressure were measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and after 8, 16 , 24 and 32 weeks. Outcome is reported as percentage of participants achieving overall blood pressure control (msSBP <140 mmHg and msDBP <90 mmHg) at weeks 8, 16, 24 & 32 endpoints.	Baseline to week 8, 16, 24 and 32 endpoints	No