Amlodipine vs Nitrates Study in Patients With Chronic Stable Angina - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00143195

Purpose

The objective of study is to compare the anti-ischemic efficacy and safety profiles of once daily amlodipine or isosorbide-5-mononitrate in the treatment of stable asymptomatic and symptomatic myocardial ischemia

Condition	Intervention	Phase
Myocardial Ischemia	Drug: Amlodipine Drug: iso- 5 - mononitrate Procedure: Blood tests Procedure: Exercise Stress Test	Phase IV

MedlinePlus related topics: Angina Depression

Drug Information available for: Amlodipine Amlodipine besylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Open Label Study Comparing Amlodipine vs Long-Acting Nitrates in Patients With Chronic Stable Angina.

Further study details as provided by Pfizer:

Primary Outcome Measures:

Evaluate the time to 1mm ST depression

Secondary Outcome Measures:

The number of patients experiencing angina attacks The frequency of hospitalizations due to angina attacks Time to onset of 1mm ST segment depression Total external workload performed Safety

Estimated Enrollment:	200
Study Start Date:	April 2001
Estimated Study Completion Date:	January 2005

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 with diagnosed clinically stable angina pectoris

Exclusion Criteria:

Patients with congestive heart failure, clinically significant cardiovascular disease, standing systolic blood pressure of less than 100mmHg, concomitant anti-anginal therapies similar to sublingual NTG

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143195

Locations

Greece
Pfizer Investigational Site
Athens, Greece, 123 51
Pfizer Investigational Site
ATHENS, Greece
Pfizer Investigational Site
Patra, Greece, 26335
Pfizer Investigational Site
Voula/Athens, Greece
Pfizer Investigational Site
loannina, Greece, 45500
Pfizer Investigational Site
Thessaloniki, Greece, 54639
Pfizer Investigational Site
Holargos/Athens, Greece, 11525
Pfizer Investigational Site
Thessaloniki, Greece, 546 36
Pfizer Investigational Site
N. Ionia, Greece, 143 88
Pfizer Investigational Site
Rio, Patra, Greece, 26499
Pfizer Investigational Site
Zakynthos, Greece, 29100
Greece, Attika
Pfizer Investigational Site
Athens, Attika, Greece, 11527

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:	A0531076
Study First Received:	August 31, 2005
Last Updated:	April 17, 2007
ClinicalTrials.gov Identifier:	NCT00143195
Health Authority:	Greece: National Organization of Medicines

Study placed in the following topic categories:

Calcium, Dietary
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Angina Pectoris
Ischemia
Amlodipine

Additional relevant MeSH terms:

Membrane Transport Modulators
Vasodilator Agents
Pathologic Processes
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 16, 2009