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An Assessment of Long Term Safety of the Combination of Aliskiren / Amlodipine in Patients With High Blood Pressure

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ClinicalTrials.gov Identifier: NCT00402103
Recruitment Status : Completed
First Posted : November 22, 2006
Results First Posted : January 11, 2011
Last Update Posted : March 10, 2011
Sponsor:
Information provided by:
Novartis

Study Description
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Brief Summary:
To assess the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg / amlodipine 10 mg in patients with essential hypertension (Mean Sitting Diastolic Blood Pressure [msDBP] ≥ 90 mmHg and < 110 mmHg).

Condition or disease Intervention/treatment Phase
Hypertension Drug: Aliskiren Drug: Amlodipine Drug: Hydrochlorothiazide Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 556 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 54-week, Open-label, Multicenter Study to Assess the Long-term Safety and Tolerability of the Combination of Aliskiren 300 mg / Amlodipine 10 mg in Patients With Essential Hypertension
Study Start Date : November 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Aliskiren/Amlodipine Drug: Aliskiren
All patients received aliskiren 150 mg for the first two weeks; dose was then force-titrated to aliskiren 300 mg for 52 weeks duration

Drug: Amlodipine
All patients received amlodipine 5 mg for the first two weeks; dose was then force-titrated to amlodipine 10 mg for 52 weeks duration
Experimental: Aliskiren/Amlodipine/HCTZ Drug: Aliskiren
All patients received aliskiren 150 mg for the first two weeks; dose was then force-titrated to aliskiren 300 mg for 52 weeks duration

Drug: Amlodipine
All patients received amlodipine 5 mg for the first two weeks; dose was then force-titrated to amlodipine 10 mg for 52 weeks duration

Drug: Hydrochlorothiazide
Optional addition of Hydrochlorothiazide (HCTZ)of 12.5 mg with increase to 25 mg was allowed for patients not adequately controlled.


Outcome Measures
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Primary Outcome Measures :
  1. Overall Percentage of Patients With Adverse Events [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Change in Mean Sitting Diastolic Blood Pressure (msDBP)From Baseline to the Indicated Time Points [ Time Frame: Baseline, Week 2, Week 4, Week 6, Week 10, Week 14, Week 28, Week 41 and Week 54 ]
  2. Percentage of Patients Achieving a Blood Pressure Control Target of <140/90 mmHg [ Time Frame: Baseline, Week 2, Week 10, Week 28 and Week 54 ]
  3. Percentage of Patients Achieving a Response in Mean Sitting Diastolic Blood Pressure (msDBP) [ Time Frame: Baseline, Week 2, Week 10, Week 28 and Week 54 ]

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:

  • Outpatients 18 years of age or older
  • Male or female patients are eligible
  • For newly diagnosed/untreated patients with essential hypertension defined as msDBP ≥ 90 and < 110 mmHg at Visit 1 and Visit 4
  • For previously treated patients with essential hypertension defined as msDBP ≥ 90 and < 110 mmHg after 2 to 4 weeks of washout (Visit 4)

Exclusion Criteria:

  • Severe hypertension
  • History or evidence of a secondary form of hypertension
  • History of Hypertensive encephalopathy or cerebrovascular accident.

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): NCT00402103


Locations
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United States, New Mexico
Investigative Site
Santa Fe, New Mexico, United States
Belgium
Investigator Site
Investigative Site, Belgium
Denmark
Investigative Center
Investigative Center, Denmark
Finland
Investigative Site
Investigative Site, Finland
Germany
Investigative Center
Investigative Center, Germany
Iceland
Investigative Site
Investigative Site, Iceland
India
Investigative Site
Investigative Site, India
Switzerland
Investigative Site
Investigative Site, Switzerland
Sponsors and Collaborators
Novartis
Investigators
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Study Chair: Novartis Pharmaceuticals Novartis
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00402103    
Other Study ID Numbers: CSPA100A2301
First Posted: November 22, 2006    Key Record Dates
Results First Posted: January 11, 2011
Last Update Posted: March 10, 2011
Last Verified: March 2011
Keywords provided by Novartis:
Hypertension, aliskiren, amlodipine, HCTZ, blood pressure
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Hydrochlorothiazide
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors