Open Label Study To Assess The Effectiveness Of Amlodipine-Atorvastatin Combination In Hypertension And Dyslipidemia. - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00174304

Purpose

To evaluate the effectiveness of amlodipine/atorvastatin therapy by assessing the percentage of subjects who reach target blood pressure (BP) and LDL-C targets as defined by their governing guidelines.

Condition	Intervention	Phase
Hypertension Hyperlipidemia	Drug: Amlodipine/atorvastatin single pill	Phase IV

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Atorvastatin Atorvastatin calcium Amlodipine Amlodipine besylate Caduet

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	An International, Multicentre, Open Label Study To Assess The Effectiveness Of Amlodipine/Atorvastatin Combination In Subjects With Hypertension And Dyslipidaemia.

Further study details as provided by Pfizer:

Primary Outcome Measures:

To evaluate the effectiveness of amlodipine/atorvastatin therapy by assessing percentage of subjects who reach target BP and LDL-C targets as defined by their governing guidelines.

Secondary Outcome Measures:

To asses changes since baseline of lab parameters, BP, safety of titration of amlodipine.atorvastatin to reach targets, to validate Expectations and Satisfaction with Treatment questionnaires.

Estimated Enrollment:	1120
Study Start Date:	October 2004
Estimated Study Completion Date:	September 2006

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Treated or untreated subjects with concurrent hypertension and dyslipidemia with BP and LDL-C not at target according to governing guidelines

Exclusion Criteria:

High liver enzymes

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174304

Show 105 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org posting This link exits the ClinicalTrials.gov site

Study ID Numbers:	A3841029
Study First Received:	September 9, 2005
Last Updated:	April 17, 2007
ClinicalTrials.gov Identifier:	NCT00174304
Health Authority:	Italy: Ministry of Health

Study placed in the following topic categories:

Calcium, Dietary
Metabolic Diseases
Hyperlipidemias
Vascular Diseases
Metabolic disorder

Atorvastatin
Dyslipidemias
Amlodipine
Lipid Metabolism Disorders
Hypertension

Additional relevant MeSH terms:

Antimetabolites
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Calcium Channel Blockers
Enzyme Inhibitors
Cardiovascular Agents

Anticholesteremic Agents
Antihypertensive Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Membrane Transport Modulators
Therapeutic Uses
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009