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

October 7, 2011 updated by: Novartis

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1254

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aliskiren + Amlodipine
Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
Drug: Amlodipine
Amlodipine (5 mg and 10 mg) was provided as capsules taken orally once daily.
Other Names:
  • Norvasc
Drug: hydrochlorothiazide
Hydrochlorothiazide 12.5 mg capsules were taken orally once daily
Other Names:
  • HydroDIURIL
  • Esidrix
  • Ezide
  • Oretic
  • Hydro-Par
Drug: Aliskiren
Aliskiren 150 mg and aliskiren 300 mg were provided as film-coated tablets, taken orally once daily.
Other Names:
  • SPA 100
Experimental: Aliskiren Start - Amlodipine Add-On
Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
Drug: Amlodipine
Amlodipine (5 mg and 10 mg) was provided as capsules taken orally once daily.
Other Names:
  • Norvasc
Drug: hydrochlorothiazide
Hydrochlorothiazide 12.5 mg capsules were taken orally once daily
Other Names:
  • HydroDIURIL
  • Esidrix
  • Ezide
  • Oretic
  • Hydro-Par
Drug: Aliskiren
Aliskiren 150 mg and aliskiren 300 mg were provided as film-coated tablets, taken orally once daily.
Other Names:
  • SPA 100
Experimental: Amlodipine Start- Aliskiren Add-On
Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
Drug: Amlodipine
Amlodipine (5 mg and 10 mg) was provided as capsules taken orally once daily.
Other Names:
  • Norvasc
Drug: hydrochlorothiazide
Hydrochlorothiazide 12.5 mg capsules were taken orally once daily
Other Names:
  • HydroDIURIL
  • Esidrix
  • Ezide
  • Oretic
  • Hydro-Par
Drug: Aliskiren
Aliskiren 150 mg and aliskiren 300 mg were provided as film-coated tablets, taken orally once daily.
Other Names:
  • SPA 100

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 24
Time Frame: Baseline to 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 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 32
Time Frame: Baseline to 32 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 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
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
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
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 24
Time Frame: Baseline to 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 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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

November 24, 2008

First Submitted That Met QC Criteria

November 24, 2008

First Posted (Estimate)

November 25, 2008

Study Record Updates

Last Update Posted (Estimate)

October 17, 2011

Last Update Submitted That Met QC Criteria

October 7, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPA100A2307

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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