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

Verified by: Novartis, March 2011
First Received: November 18, 2006 | Last Updated: March 8, 2011 | Phase: Phase 3 | Start Date: November 2006
Overall Status: Completed | Estimated Enrollment: 556
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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)...

Brief Summary

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”

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).

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: April 2008

Intervention(s) in this Clinical Trial

  • 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.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Aliskiren/Amlodipine
  • Experimental: Aliskiren/Amlodipine/HCTZ

Outcome Measures for this Clinical Trial

Primary Measures

  • Overall Percentage of Patients With Adverse Events
    • Time Frame: 52 weeks
      Safety Issue?: Yes

Secondary Measures

  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Novartis Industry

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Chair Novartis  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00402103

Study ID Number: CSPA100A2301

ClinicalTrials.gov Identifier: NCT00402103

Health Authority: United States: Food and Drug Administration

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