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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00797862
First received: November 24, 2008
Last updated: October 7, 2011
Last verified: June 2011

November 24, 2008
October 7, 2011
November 2008
November 2010   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 24 [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: No ]
    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.
Change in vital signs at every visit [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00797862 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 32 [ Time Frame: Baseline to 32 weeks ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 24 [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • Change in vital signs at every visit [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
  • Adverse event at every visit [ Time Frame: 32 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in Biomarker assessments [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Aliskiren and the Calcium Channel Blocker Amlodipine Combination as an Initial Treatment Strategy for Hypertension
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Hypertension
  • 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 + 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.
    Interventions:
    • Drug: Amlodipine
    • Drug: hydrochlorothiazide
    • Drug: Aliskiren
  • 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.
    Interventions:
    • Drug: Amlodipine
    • Drug: hydrochlorothiazide
    • Drug: Aliskiren
  • 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.
    Interventions:
    • Drug: Amlodipine
    • Drug: hydrochlorothiazide
    • Drug: Aliskiren
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1254
November 2010
November 2010   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Costa Rica,   France,   Germany,   Greece,   Guatemala,   South Africa,   Switzerland,   United Kingdom,   Venezuela
 
NCT00797862
CSPA100A2307
No
External Affairs, Novartis Pharmaceuticals
Novartis
Not Provided
Study Chair: Novartis Novartis
Novartis
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP