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Amlodipine vs Nitrates Study in Patients With Chronic Stable Angina (ANISSA)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00143195
First received: August 31, 2005
Last updated: April 17, 2007
Last verified: April 2007
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Study Comparing Amlodipine vs Long-Acting Nitrates in Patients With Chronic Stable Angina.

Resource links provided by NLM:

U.S. FDA Resources

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, Attika, Greece, 11527
Pfizer Investigational Site
Athens, Greece, 123 51
Pfizer Investigational Site
Athens, Greece
Pfizer Investigational Site
Holargos/Athens, Greece, 11525
Pfizer Investigational Site
Loannina, Greece, 45500
Pfizer Investigational Site
N. Ionia, Greece, 143 88
Pfizer Investigational Site
Patra, Greece, 26335
Pfizer Investigational Site
Rio, Patra, Greece, 26499
Pfizer Investigational Site
Thessaloniki, Greece, 54639
Pfizer Investigational Site
Thessaloniki, Greece, 546 36
Pfizer Investigational Site
Voula/Athens, Greece
Pfizer Investigational Site
Zakynthos, Greece, 29100
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

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

No publications provided

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

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Ischemia
Angina Pectoris
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Chest Pain
 Pain
Signs and Symptoms
Amlodipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 23, 2013