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


Tracking Information

Start Date  ICMJEJanuary 2009
Estimated Primary Completion DateDecember 2009   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: February 10, 2009)		Change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00841672 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: February 10, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEEfficacy 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
Official Title  ICMJEAn 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
Brief Summary

This study will compare the 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.

Detailed Description 
Study PhasePhase IV
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment
Condition  ICMJEModerate to Severe Hypertension
Intervention  ICMJE
  • Drug: Aliskiren/Amlodipine
    Aliskiren 300mg plus Amlodipine 10mg
  • Drug: Amlodipine
    Amlodipine 10mg
Study Arms / Comparison Groups
  • 2: Active Comparator
    Amlodipine 10mg
    Intervention: Drug: Amlodipine
  • 1: Experimental
    Aliskiren 300mg plus Amlodipine 10mg
    Intervention: Drug: Aliskiren/Amlodipine

Recruitment Information

Estimated Enrollment  ICMJE484
Completion Date 
Estimated Primary Completion DateDecember 2009   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Moderate to severe hypertension
  • Pregnant or nursing (lactating) women
  • Women of child-bearing potential
  • Previous or current diagnosis of heart failure (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

Other protocol-defined inclusion/exclusion criteria may apply

GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Novartis41-61-324-1111
Location Countries  ICMJECzech Republic,   Germany,   Philippines,   Romania,   Russian Federation,   Singapore,   Spain

Administrative Information

NCT ID  ICMJENCT00841672
Responsible PartyExternal Affairs, Novartis
Study ID Numbers  ICMJECSPA100A2306
Study Sponsor  ICMJENovartis
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:NovartisNovartis
Information Provided ByNovartis