Aliskiren and the Calcium Channel Blocker Amlodipine Combination as an Initial Treatment Strategy for Hypertension (ACCELERATE)
This study has been completed.
Sponsor:
Novartis
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00797862
First received: November 24, 2008
Last updated: October 7, 2011
Last verified: June 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Amlodipine Drug: hydrochlorothiazide Drug: Aliskiren |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Enrollment: | 1254 |
| Study Start Date: | November 2008 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
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:
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:
Drug: Aliskiren
Aliskiren 150 mg and aliskiren 300 mg were provided as film-coated tablets, taken orally once daily.
Other Name: SPA 100
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00797862
Locations
| 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
| Study Chair: | Novartis | Novartis |
More Information
No publications provided by Novartis
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | External Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00797862 History of Changes |
| Other Study ID Numbers: | CSPA100A2307 |
| Study First Received: | November 24, 2008 |
| Results First Received: | April 21, 2011 |
| Last Updated: | October 7, 2011 |
| Health Authority: | Canada: Health Canada Costa Rica: Ministry of Health Costa Rica France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Guatemala: Ministry of Public Health and Social Assistance Greece: National Organization of Medicines South Africa: Medicines Control Council Switzerland: Swissmedic United Kingdom: Medicines and Healthcare Products Regulatory Agency Venezuela: Ministry of Health and Social Development |
Keywords provided by Novartis:
|
Aliskiren Amlodipine Hypertension SPA1000 Norvasc |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Calcium Channel Blockers Amlodipine Hydrochlorothiazide Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Cardiovascular Agents Therapeutic Uses Diuretics Natriuretic Agents Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Antihypertensive Agents Vasodilator Agents |
ClinicalTrials.gov processed this record on May 19, 2013