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

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ClinicalTrials.gov Identifier: NCT00778921
Recruitment Status : Completed
First Posted : October 24, 2008
Results First Posted : March 23, 2011
Last Update Posted : October 27, 2016
Sponsor:
Information provided by:
Novartis

Study Description
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Brief Summary:
This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients with hypertension not adequately controlled with amlodipine alone.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Amlodipine 10 mg Drug: Aliskiren 150 Drug: Amlodipine 300 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 847 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Eight Week Double-blind, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / Amlodipine (150/10 mg and 300/10 mg) in Comparison With Amlodipine 10 mg in Patients With Essential Hypertension Not Adequately Responsive to Amlodipine 10 mg Monotherapy
Study Start Date : October 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Amlodipine 10 mg
Amlodipine 10 mg
 Drug: Amlodipine 10 mg
Amlodipine 10 mg
Experimental: Aliskiren/Amlodipine 150/10 mg
Aliskiren/Amlodipine 150/10 mg
 Drug: Amlodipine 10 mg
Amlodipine 10 mg

Drug: Aliskiren 150
Aliskiren/Amlodipine 150/10 mg
Experimental: Aliskiren/Amlodipine 300/10 mg
Aliskiren/Amlodipine 300/10 mg
 Drug: Amlodipine 10 mg
Amlodipine 10 mg

Drug: Amlodipine 300
Aliskiren/Amlodipine 300/10 mg


Outcome Measures
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Primary Outcome Measures :
  1. Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study [ Time Frame: Baseline and Week 8 ]

Secondary Outcome Measures :
  1. Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study [ Time Frame: Baseline and Week 8 ]
  2. Number of Patients With Any Adverse Event and/or Serious Adverse Event in the Double-blind Period by Treatment Group [ Time Frame: 8 weeks ]
  3. Biomarker Assessment at Visit 2 (Single Blind Run in), Visit 5 (Randomization), and Visit 9 (EOS) [ Time Frame: 12 weeks ]

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:

  • Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a 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 5 (randomization)

Exclusion Criteria:

  • Severe hypertension
  • Pregnant or nursing (lactating) women
  • Pre-menopausal women not taking accepted form of birth control
  • Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1
  • History of cardiovascular conditions
  • Uncontrolled Type 1 or Type 2 diabetes mellitus
  • Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with similar chemical structures

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): NCT00778921


Locations
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Argentina
Investigative Site
Buenos Aires, Argentina
Germany
Investigative Site
Berlin, Germany
Norway
Investigative Site
Oslo, Norway
Poland
Investigative Site
Warsaw, Poland
Slovakia
Investigative Site
Bratislava, Slovakia
Sweden
Investigative Site
Stockholm, Sweden
Turkey
Investigative Site
Ankara, Turkey
Sponsors and Collaborators
Novartis
Investigators
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Study Chair: Novartis N
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Study Director, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00778921    
Other Study ID Numbers: CSPA100A2304
First Posted: October 24, 2008    Key Record Dates
Results First Posted: March 23, 2011
Last Update Posted: October 27, 2016
Last Verified: February 2011
Keywords provided by Novartis:
Aliskiren
Amlodipine
Non-responder to 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