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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00402103
First received: November 18, 2006
Last updated: March 8, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
Hypertension
Drug: Aliskiren
Drug: Amlodipine
Drug: Hydrochlorothiazide
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Overall Percentage of Patients With Adverse Events [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]

Enrollment: 556
Study Start Date: November 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402103

Locations
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
Study Chair: Novartis Pharmaceuticals Novartis
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00402103     History of Changes
Other Study ID Numbers: CSPA100A2301
Study First Received: November 18, 2006
Results First Received: December 13, 2010
Last Updated: March 8, 2011
Health Authority: United States: Food and Drug Administration
Belgium: Ministry of Social Affairs, Public Health and the Environment
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
India: Ministry of Health
Switzerland: Swissmedic

Keywords provided by Novartis:
Hypertension, aliskiren, amlodipine, HCTZ, blood pressure

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Hydrochlorothiazide
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014