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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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00778921
First received: October 23, 2008
Last updated: February 25, 2011
Last verified: February 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Hypertension
 Drug: Amlodipine 10 mg
Drug: Aliskiren 150
Drug: Amlodipine 300
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
  • Number of Patients With Any Adverse Event and/or Serious Adverse Event in the Double-blind Period by Treatment Group [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Biomarker Assessment at Visit 2 (Single Blind Run in), Visit 5 (Randomization), and Visit 9 (EOS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 847
Study Start Date: October 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00778921

Locations
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
Study Chair: Novartis N
  More Information

No publications provided

Responsible Party: Study Director, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00778921     History of Changes
Other Study ID Numbers: CSPA100A2304
Study First Received: October 23, 2008
Results First Received: December 13, 2010
Last Updated: February 25, 2011
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Germany: Federal Institute for Drugs and Medical Devices
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Sweden: Medical Products Agency
Slovakia: State Institute for Drug Control
Turkey: Ministry of Health

Keywords provided by Novartis:
Aliskiren
Amlodipine
Non-responder to Amlodipine

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

ClinicalTrials.gov processed this record on June 18, 2013