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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

February 10, 2009
July 5, 2011
January 2009
September 2009   (final data collection date for primary outcome measure)
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)
Change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00841672 on ClinicalTrials.gov Archive Site
  • 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
  • Change from baseline in mean sitting diastolic blood pressure (msDBP) after 8 weeks of treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • The proportion of patients achieving blood pressure control (msSBP < 140 mmHg and msDBP < 90 mmHg), in both study arms, after 8 weeks of treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • The proportion of patients achieving the systolic blood pressure response (msSBP < 140 mmHg or a reduction ≥ 20 mmHg from the baseline), in both study arms, after 8 weeks of treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • The proportion of patients achieving the diastolic blood pressure response (msDBP < 90 mmHg or a reduction ≥10 mmHg from the baseline), in both study arms, after 8 weeks of treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Reduction in amlodipine-induced edema [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Moderate to Severe Hypertension
  • 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.
  • 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.
  • 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.
    Intervention: Drug: Aliskiren/amlodipine 300/10 mg tablet
  • 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.
    Intervention: Drug: Amlodipine 10 mg capsule
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
485
September 2009
September 2009   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Philippines,   Romania,   Russian Federation,   Singapore,   Spain
 
NCT00841672
CSPA100A2306
Not Provided
External Affairs, Novartis
Novartis
Not Provided
Study Director: Novartis Novartis
Novartis
July 2011

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