NCT00143195

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2001

Longer than P75 for phase_4

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

First QC Date

August 31, 2005

Last Update Submit

January 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluate the time to 1mm ST depression

Secondary Outcomes (1)

  • 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

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Outpatients \> =18 years of age with diagnosed clinically stable angina pectoris

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Pfizer Investigational Site

Athens, Attica, 11527, Greece

Location

Pfizer Investigational Site

Athens, 123 51, Greece

Location

Pfizer Investigational Site

Athens, Greece

Location

Pfizer Investigational Site

Holargos/Athens, 11525, Greece

Location

Pfizer Investigational Site

Loannina, 45500, Greece

Location

Pfizer Investigational Site

N. Ionia, 143 88, Greece

Location

Pfizer Investigational Site

Pátrai, 26335, Greece

Location

Pfizer Investigational Site

Rio, Patra, 26499, Greece

Location

Pfizer Investigational Site

Thessaloniki, 546 36, Greece

Location

Pfizer Investigational Site

Thessaloniki, 54639, Greece

Location

Pfizer Investigational Site

Voula/Athens, Greece

Location

Pfizer Investigational Site

Zakynthos, 29100, Greece

Location

Related Links

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

AmlodipineIsosorbideHematologic TestsExercise Test

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsSorbitolSugar AlcoholsAlcoholsOrganic ChemicalsCarbohydratesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesHeart Function TestsDiagnostic Techniques, CardiovascularRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometry

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 2, 2005

Study Start

April 1, 2001

Study Completion

January 1, 2005

Last Updated

January 28, 2021

Record last verified: 2021-01

Locations