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Efficacy and Safety of the Combination of Aliskiren (300 mg) and Amlodipine (10 mg) Compared to Amlodipine (10 mg) Monotherapy in Patients With Moderate to Severe Hypertension

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ClinicalTrials.gov Identifier: NCT00841672
Recruitment Status : Completed
First Posted : February 11, 2009
Results First Posted : June 27, 2011
Last Update Posted : July 12, 2011
Sponsor:
Information provided by:
Novartis

Study Description
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Brief Summary:
This study will compare the blood pressure (BP) lowering effect of the combination of aliskiren/amlodipine 300/10 mg versus amlodipine 10 mg monotherapy in patients with moderate to severe hypertension by testing the hypothesis that the combination of aliskiren/amlodipine produces a superior reduction from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment.

Condition or disease Intervention/treatment Phase
Moderate to Severe Hypertension Drug: Aliskiren/amlodipine 300/10 mg tablet Drug: Amlodipine 10 mg capsule Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 485 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: An 8-week, Double-blind, Randomized, Parallel Group, Multi-center Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren 300 mg and Amlodipine 10 mg Compared to Amlodipine 10 mg in Patients
Study Start Date : January 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Aliskiren/amlodipine 300/10 mg tablet
Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
 Drug: Aliskiren/amlodipine 300/10 mg tablet
Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of two tablets and one capsule of study medication per day throughout the study.
Active Comparator: Amlodipine 10 mg capsule
Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
 Drug: Amlodipine 10 mg capsule
Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of two tablets and one capsule of study medication per day throughout the study.


Outcome Measures
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Primary Outcome Measures :
  1. Mean Sitting Systolic Blood Pressure (msSBP) [ Time Frame: Baseline to end of study (Week 8) ]
    Change in mean sitting systolic blood pressure (msSBP) from baseline to end of study (Week 8)


Secondary Outcome Measures :
  1. Mean Sitting Diastolic Blood Pressure (msDBP) [ Time Frame: Baseline to end of study (Week 8) ]
    Change in mean sitting diastolic blood pressure (msDBP) from baseline to end of study (Week 8)

  2. Systolic Blood Pressure Response [ Time Frame: Baseline to end of study (Week 8) ]
    Percentage of patients achieving a mean sitting systolic blood pressure response (msSBP < 140 mmHg or a reduction => 20 mmHg from the baseline) from baseline to end of study (Week 8)

  3. Diastolic Blood Pressure Response [ Time Frame: Baseline to end of study (Week 8) ]
    Percentage of patients achieving a mean sitting diastolic blood pressure response (msDBP < 90 mmHg or a reduction ≥ 10 mmHg from the baseline) from baseline to end of study (Week 8)

  4. Blood Pressure Control [ Time Frame: End of study (Week 8) ]
    Percentage of patients achieving blood pressure control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at end of study


Eligibility Criteria
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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:

  • Outpatients ≥ 18 years of age
  • Patients with a diagnosis of moderate to severe hypertension, defined as msSBP ≥ 160 mmHg and < 200 mmHg at Visit 2

Exclusion Criteria:

  • Mild to moderate hypertension
  • Pregnant or nursing (lactating) women
  • Women of child-bearing potential
  • Previous or current diagnosis of heart failure New York Heart Association(NYHA) Class II-IV.
  • Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1.
  • Uncontrolled Type 1 or Type 2 diabetes mellitus
  • Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with Similar chemical structures
  • History of hypertensive encephalopathy or cerebrovascular accident, or history of transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention
  • Patients on a combination of 3 or more antihypertensive medications

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): NCT00841672


Locations
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Germany
Investigative Site
Berlin, Germany
Philippines
Investigative Site
Manilla, Philippines
Romania
Investigative Site
Bucharest, Romania
Russian Federation
Investigative Site
Moscow, Russian Federation
Singapore
Investigative Site
Singapore, Singapore
Spain
Investigative Site
Madrid, Spain
Sponsors and Collaborators
Novartis
Investigators
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Study Director: Novartis Novartis
More Information
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Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00841672    
Other Study ID Numbers: CSPA100A2306
First Posted: February 11, 2009    Key Record Dates
Results First Posted: June 27, 2011
Last Update Posted: July 12, 2011
Last Verified: July 2011
Keywords provided by Novartis:
Hypertension
systolic blood pressure
cardiovascular disease
aliskiren
amlodipine
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents