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Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients Not Adequately Responding to Aliskiren Alone

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ClinicalTrials.gov Identifier: NCT00777946
Recruitment Status : Completed
First Posted : October 22, 2008
Results First Posted : June 15, 2011
Last Update Posted : July 12, 2011
Sponsor:
Information provided by:
Novartis

Tracking Information
First Submitted Date  ICMJE October 20, 2008
First Posted Date  ICMJE October 22, 2008
Results First Submitted Date  ICMJE December 13, 2010
Results First Posted Date  ICMJE June 15, 2011
Last Update Posted Date July 12, 2011
Study Start Date  ICMJE October 2008
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2011)
Change From Baseline to End of Study in the Mean Sitting Diastolic Blood Pressure (msDBP) [ Time Frame: Baseline, End of Study (Week 8) ]
After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. The difference of the msDBP at baseline from the msDBP at 8 weeks was calculated using an Analysis of Covariance (ANCOVA) model with baseline as a covariate and treatment and region as two factors.
Original Primary Outcome Measures  ICMJE
 (submitted: October 21, 2008)
Vital signs at every visit [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT00777946 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2011)
  • Change From Baseline to End of Study in the Mean Sitting Systolic Blood Pressure (msSBP) [ Time Frame: Baseline, End of Study (Week 8) ]
    After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. The difference of the msSBP at baseline from the msSBP at 8 weeks was calculated using an ANCOVA model with baseline as a covariate and treatment and region as two factors.
  • Number of Participants With Serious Adverse Events and Adverse Events [ Time Frame: 8 weeks ]
    The number of participants with any Serious Adverse Event and the number of participants with Adverse Events in any system organ class. Additional information about Adverse Events can be found in the Adverse Event Section.
  • Percentage of Participants Achieving Blood Pressure Control [ Time Frame: 8 weeks ]
    After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. Blood Pressure control was defined as having a mean sitting Diastolic Blood Pressure <90 and a mean sitting Systolic Blood Pressure <140.
  • Percentage of Participants Achieving a Diastolic Blood Pressure Response [ Time Frame: 8 weeks ]
    After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A Diastolic Blood Pressure Response was defined as a mean sitting Diastolic Blood Pressure (msDBP) <90 mmHg or a ≥ 10 mmHg reduction in msDBP from baseline.
  • Percentage of Participants Achieving a Systolic Blood Pressure Response [ Time Frame: 8 weeks ]
    After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A Systolic Blood Pressure Response was defined as a mean sitting Systolic Blood Pressure (msSBP) <140 mmHg or a ≥ 20 mmHg reduction in msSBP from baseline.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2008)
  • Vital signs at every visit [ Time Frame: 12 weeks ]
  • Adverse event at every visit [ Time Frame: 12 weeks ]
  • Biomarker assessment at visit 2 (single blind run in), visit 4 (randomization), and visit 8 (EOS) [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients Not Adequately Responding to Aliskiren Alone
Official Title  ICMJE A Randomized, Eight-week Double-blind, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / Amlodipine (300/5 mg and 300/10 mg) in Comparison With Aliskiren 300 mg in Patients With Essential Hypertension Not Adequately Responsive to Aliskiren 300 mg Monotherapy
Brief Summary This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients not adequately controlled with aliskiren alone
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: Aliskiren 300 mg
    Aliskiren 300 mg tablet taken orally once a day with a glass of water.
  • Drug: Aliskiren/Amlodipine 300/5 mg
    Aliskiren/Amlodipine 300/5 mg tablet taken orally once a day with a glass of water.
  • Drug: Aliskiren/Amlodipine 300/10 mg
    Aliskiren/Amlodipine 300/10 mg taken orally once a day with a glass of water.
  • Drug: Placebo to Aliskiren
    Placebo to Aliskiren tablet taken orally once a day.
  • Drug: Placebo to Aliskiren/Amlodipine
    Placebo to Aliskiren/Amlodipine taken orally once a day.
Study Arms  ICMJE
  • Experimental: Aliskiren 300 mg/Amlodipine 5 mg
    Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
    Interventions:
    • Drug: Aliskiren/Amlodipine 300/5 mg
    • Drug: Placebo to Aliskiren
  • Experimental: Aliskiren 300 mg/Amlodipine 10 mg
    Participants received 1 Aliskiren/Amlodipine 300/10 mg tablet + 1 Placebo to Aliskiren tablet orally once daily in the morning for 8 weeks.
    Interventions:
    • Drug: Aliskiren/Amlodipine 300/10 mg
    • Drug: Placebo to Aliskiren
  • Active Comparator: Aliskiren 300 mg
    Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
    Interventions:
    • Drug: Aliskiren 300 mg
    • Drug: Placebo to Aliskiren/Amlodipine
Publications * Glorioso N, Thomas M, Troffa C, Argiolas G, Patel S, Baek I, Zhang J. Antihypertensive efficacy and tolerability of aliskiren/amlodipine single- pill combinations in patients with an inadequate response to aliskiren monotherapy. Curr Vasc Pharmacol. 2012 Nov;10(6):748-55.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 9, 2009)
818
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2008)
726
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a mean sitting Diastolic Blood Pressure (msDBP) ≥ 95 mmHg and < 110 mmHg at Visits 1 and 2
  • Patients who have been treated for hypertension within the 4 weeks prior to - Visit 1 must have a msDBP ≥ 90 mmHg and < 110 mmHg at Visit 2
  • All patients must have a msDBP ≥ 90 mmHg and < 110 mmHg at Visit 4

Exclusion Criteria:

  • Severe 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

Other protocol-defined inclusion/exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Estonia,   France,   Iceland,   India,   Italy,   Korea, Republic of,   Lithuania,   Spain,   Venezuela
Removed Location Countries South Africa
 
Administrative Information
NCT Number  ICMJE NCT00777946
Other Study ID Numbers  ICMJE CSPA100A2303
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party External Affairs, Novartis
Study Sponsor  ICMJE Novartis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Novartis Novartis
PRS Account Novartis
Verification Date June 2011

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