A Clinical Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren and Amlodipine in Hypertensive Non Responders Patients

This study has been completed.

First Received: September 12, 2005 Last Updated: September 25, 2008 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00219076

Purpose

To evaluate the blood pressure lowering effect and safety of aliskiren 150 mg used in combination with amlodipine 5 mg in patients with essential hypertension not adequately responsive to amlodipine 5 mg.

Condition	Intervention	Phase
Hypertension	Drug: aliskiren	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Six-Week, Randomized, Double-Blind, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren 150 mg and Amlodipine 5 mg Compared to Amlodipine 5 mg and 10 mg in Hypertensive Patients Not Adequately Responsive to Amlodipine 5 mg

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate Aliskiren

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in mean sitting diastolic blood pressure after 6 weeks

Secondary Outcome Measures:

Change from baseline in mean sitting systolic blood pressure after 6 weeks
Mean sitting diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 6 weeks
Achieve mean sitting blood pressure target of < 140/90 mmHg after 6 weeks
Change from baseline in standing diastolic blood pressure after 6 weeks
Change from baseline in standing systolic blood pressure after 6 weeks

Estimated Enrollment:	504
Study Start Date:	February 2005
Primary Completion Date:	October 2005 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

Inclusion Criteria

Patients with essential hypertension
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 exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219076

Locations

United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States
Germany

Investigative Centers, Germany

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	CSPP100A2305
Study First Received:	September 12, 2005
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00219076 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Hypertension, aliskiren, blood pressure, amlodipine

Study placed in the following topic categories:

Calcium, Dietary
Vasodilator Agents
Vascular Diseases
Calcium Channel Blockers

Cardiovascular Agents
Antihypertensive Agents
Amlodipine
Hypertension

Additional relevant MeSH terms:

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

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Amlodipine
Hypertension

ClinicalTrials.gov processed this record on September 01, 2009