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

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ClinicalTrials.gov Identifier: NCT00797862
Recruitment Status : Completed
First Posted : November 25, 2008
Results First Posted : May 17, 2011
Last Update Posted : October 17, 2011
Sponsor:
Information provided by:
Novartis

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Amlodipine Drug: hydrochlorothiazide Drug: Aliskiren Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
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 Start Date : November 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Norvasc

Drug: hydrochlorothiazide
Hydrochlorothiazide 12.5 mg capsules were taken orally once daily
Other Names:
  • Esidrix
  • HydroDIURIL
  • Oretic
  • Ezide
  • Hydro-Par

Drug: Aliskiren
Aliskiren 150 mg and aliskiren 300 mg were provided as film-coated tablets, taken orally once daily.
Other Name: 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 Name: Norvasc

Drug: hydrochlorothiazide
Hydrochlorothiazide 12.5 mg capsules were taken orally once daily
Other Names:
  • Esidrix
  • HydroDIURIL
  • Oretic
  • Ezide
  • Hydro-Par

Drug: Aliskiren
Aliskiren 150 mg and aliskiren 300 mg were provided as film-coated tablets, taken orally once daily.
Other Name: 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 Name: Norvasc

Drug: hydrochlorothiazide
Hydrochlorothiazide 12.5 mg capsules were taken orally once daily
Other Names:
  • Esidrix
  • HydroDIURIL
  • Oretic
  • Ezide
  • Hydro-Par

Drug: Aliskiren
Aliskiren 150 mg and aliskiren 300 mg were provided as film-coated tablets, taken orally once daily.
Other Name: SPA 100


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00797862


Locations
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Canada
Investigative Site
Toronto, Canada
Costa Rica
Investigative Site
San Jose, Costa Rica
France
Investigative Site
Paris, France
Germany
Investigative Site
Bonn, Germany
Greece
Investigative Site
Athens, Greece
Guatemala
Investigative Site
Guatemala city, Guatemala
South Africa
Investigative Site
Cape Town, South Africa
Switzerland
Investigative Site
Basel, Switzerland
United Kingdom
Investigative Site
London, United Kingdom
Venezuela
Investigative Site
Caracas, Venezuela
Sponsors and Collaborators
Novartis
Investigators
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Study Chair: Novartis Novartis
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00797862    
Other Study ID Numbers: CSPA100A2307
First Posted: November 25, 2008    Key Record Dates
Results First Posted: May 17, 2011
Last Update Posted: October 17, 2011
Last Verified: June 2011
Keywords provided by Novartis:
Aliskiren
Amlodipine
Hypertension
SPA1000
Norvasc
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Hydrochlorothiazide
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors