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Phase 2 N=253 Randomized Double-blind Treatment

Study of Oral PG-116800 Following a Heart Attack

Myocardial Infarction · Heart Failure · Heart Enlargement

Bottom Line

View on ClinicalTrials.gov: NCT00067236 ↗
Enrolled (actual)
253
Serious AEs
56.1%
Results posted
Nov 2011
Primary outcome: Primary: Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVi in mL/m2) at Day 90 Post Myocardial Infarction (MI) — 5.48; 5.09 mL/m2 — p=0.4239

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
PG-116800 (given as PG-530742) (Drug); Placebo tablet (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Procter and Gamble
Primary completion
Dec 2004

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVi in mL/m2) at Day 90 Post Myocardial Infarction (MI)		 5.48; 5.09 0.4239

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.

Eligibility Criteria

Inclusion:

  • Be at least 18 years of age but not older than 80 years of age at screening;
  • Be diagnosed with a heart attack based on electrocardiogram (ECG) and cardiac enzymes criteria;
  • The qualifying heart attack has to be a first heart attack;
  • The qualifying heart attack has to result in a left ventricular ejection fraction (a measure of the working efficiency of the heart) between 15% and 40%.

Exclusion:

  • Documented previous history of heart attack;
  • Any past history of heart failure;
  • Hemodynamic instability (no instability of circulatory system);
  • History of congenital heart disease and cardiomyopathy (weakened heart muscle) associated with connective tissue disorders;
  • Recent history or current moderate-to-severe kidney or liver impairment;
  • Significant blood dyscrasias (disorders of the blood cells);
  • Females who are currently: pregnant; breast-feeding; or are of childbearing potential.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00067236). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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