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

Primary Purpose

Myocardial Ischemia

Status
Completed
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Amlodipine
iso- 5 - mononitrate
Blood tests
Exercise Stress Test
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Ischemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

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

Full Information

First Posted
August 31, 2005
Last Updated
January 26, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00143195
Brief Title
Amlodipine vs Nitrates Study in Patients With Chronic Stable Angina
Acronym
ANISSA
Official Title
Open Label Study Comparing Amlodipine vs Long-acting Nitrates in Patients With Chronic Stable Angina.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2005 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Amlodipine
Intervention Type
Drug
Intervention Name(s)
iso- 5 - mononitrate
Intervention Type
Procedure
Intervention Name(s)
Blood tests
Intervention Type
Procedure
Intervention Name(s)
Exercise Stress Test
Primary Outcome Measure Information:
Title
Evaluate the time to 1mm ST depression
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Athens
State/Province
Attika
ZIP/Postal Code
11527
Country
Greece
Facility Name
Pfizer Investigational Site
City
Athens
ZIP/Postal Code
123 51
Country
Greece
Facility Name
Pfizer Investigational Site
City
Athens
Country
Greece
Facility Name
Pfizer Investigational Site
City
Holargos/Athens
ZIP/Postal Code
11525
Country
Greece
Facility Name
Pfizer Investigational Site
City
Loannina
ZIP/Postal Code
45500
Country
Greece
Facility Name
Pfizer Investigational Site
City
N. Ionia
ZIP/Postal Code
143 88
Country
Greece
Facility Name
Pfizer Investigational Site
City
Patra
ZIP/Postal Code
26335
Country
Greece
Facility Name
Pfizer Investigational Site
City
Rio, Patra
ZIP/Postal Code
26499
Country
Greece
Facility Name
Pfizer Investigational Site
City
Thessaloniki
ZIP/Postal Code
546 36
Country
Greece
Facility Name
Pfizer Investigational Site
City
Thessaloniki
ZIP/Postal Code
54639
Country
Greece
Facility Name
Pfizer Investigational Site
City
Voula/Athens
Country
Greece
Facility Name
Pfizer Investigational Site
City
Zakynthos
ZIP/Postal Code
29100
Country
Greece

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0531076&StudyName=Amlodipine+vs+NItrates+Study+in+Patients+with+Chronic+Stable++Angina+%28ANISSA%29
Description
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Amlodipine vs Nitrates Study in Patients With Chronic Stable Angina

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