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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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00841672
First received: February 10, 2009
Last updated: July 5, 2011
Last verified: July 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Mean Sitting Systolic Blood Pressure (msSBP) [ Time Frame: Baseline to end of study (Week 8) ] [ Designated as safety issue: No ]
    Change in mean sitting systolic blood pressure (msSBP) from baseline to end of study (Week 8)


Secondary Outcome Measures:
  • Mean Sitting Diastolic Blood Pressure (msDBP) [ Time Frame: Baseline to end of study (Week 8) ] [ Designated as safety issue: No ]
    Change in mean sitting diastolic blood pressure (msDBP) from baseline to end of study (Week 8)

  • Systolic Blood Pressure Response [ Time Frame: Baseline to end of study (Week 8) ] [ Designated as safety issue: No ]
    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)

  • Diastolic Blood Pressure Response [ Time Frame: Baseline to end of study (Week 8) ] [ Designated as safety issue: No ]
    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)

  • Blood Pressure Control [ Time Frame: End of study (Week 8) ] [ Designated as safety issue: No ]
    Percentage of patients achieving blood pressure control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at end of study


Enrollment: 485
Study Start Date: January 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00841672

Locations
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
Study Director: Novartis Novartis
  More Information

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00841672     History of Changes
Other Study ID Numbers: CSPA100A2306
Study First Received: February 10, 2009
Results First Received: January 5, 2011
Last Updated: July 5, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Philippines: Bureau of Food and Drugs
Spain: Spanish Agency of Medicines
Romania: National Medicines Agency

Keywords provided by Novartis:
Hypertension
systolic blood pressure
cardiovascular disease
aliskiren
amlodipine

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 25, 2014