CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 253 enrolled
Drug / intervention
PG-116800 (given as PG-530742) +1 moredrug
Likely dose
PG-116800 200 mg orally twice daily for 90 daysAI-extracted
Key inclusion· 3
  • ✓Age 18-80 years at screening
  • ✓First acute myocardial infarction diagnosed by ECG and cardiac enzyme criteria
  • ✓Left ventricular ejection fraction between 15-40%
Key exclusion· 7
  • ✕Prior myocardial infarction or heart attack
  • ✕History of heart failure
  • ✕Hemodynamic instability
  • ✕Congenital heart disease or cardiomyopathy associated with connective tissue disorders

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00067236
NCT00067236Phase 2Completed
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A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral PG-116800 Following a Heart Attack

Procter and Gamble·interventional·Posted Aug 14, 2003·Updated Nov 4, 2011

In Brief

A Phase 2 clinical trial evaluating PG-116800 (given as PG-530742) and Placebo tablet for Myocardial Infarction and 2 related conditions. Completed, enrolled 253 participants across 52 sites in 3 countries.

Detailed Summary

The main purpose of the study is to test whether a possible new drug (called PG-116800) can prevent some of the damage to heart muscle in patients who have had a heart attack. The study will also supply information regarding possible uses of this compound in cardiovascular disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyocardial Infarction, Heart Failure, Heart Enlargement
CountriesCanada, Poland, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 14, 2003
Enrollment StartSep 1, 2003
Primary CompletionDec 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 22.9 years ago

Interventions

PG-116800 (given as PG-530742)drug

200 mg tablet of PG-116800 (given as PG-530742)twice a day for 90 days

Placebo tabletdrug

placebo tablet, twice a day for 90 days