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

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00402103

Purpose

Assessing the long-term safety of the fixed-dose combination of aliskiren and amlodipine (300 mg/ 5 mg and 300 / 10 mg) in patients with essential hypertension.

Condition	Intervention	Phase
Hypertension	Drug: Aliskiren and amlodipine combination Drug: Aliskiren/Amlodipine	Phase III

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate Aliskiren

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

Further study details as provided by Novartis:

Primary Outcome Measures:

Assess long term safety of the combination of aliskiren and amlodipine [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Mean sitting diastolic blood pressure (msDBP) lowering from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Proportion of patients achieving a blood pressure control target of 140/90 mmHg [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	652
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
1: Experimental	Drug: Aliskiren and amlodipine combination 300/5 and 300/10 Drug: Aliskiren/Amlodipine Aliskiren 300/Amlodipine 10 mg

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female outpatients with hypertension; 18 years of age and older
Patients who are eligible and able to participate in the study

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

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

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CSPA100A2301
Study First Received:	November 18, 2006
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00402103
Health Authority:	United States: Food and Drug Administration; Belgium: Ministry of Social Affairs, Public Health and the Environment; Denmark: Danish Medicines Agency; Finland: National Agency for Medicines; Germany: Federal Institute for Drugs and Medical Devices; India: Ministry of Health; Switzerland: Swissmedic

Keywords provided by Novartis:

Hypertension, aliskiren, amlodipine, blood pressure

Study placed in the following topic categories:

Calcium, Dietary
Vascular Diseases
Essential hypertension
Amlodipine
Hypertension

Additional relevant MeSH terms:

Membrane Transport Modulators
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Calcium Channel Blockers

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009