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Study of Oral PG-116800 Following a Heart Attack

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Procter and Gamble
ClinicalTrials.gov Identifier:
NCT00067236
First received: August 13, 2003
Last updated: September 27, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
Heart Failure
Heart Enlargement
 Drug: PG-116800 (given as PG-530742)
Drug: Placebo tablet
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral PG-116800 Following a Heart Attack

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Procter and Gamble:

Primary Outcome Measures:
  • Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVi in mL/m2) at Day 90 Post Myocardial Infarction (MI) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Mean change of left ventricular end diastolic volume index (mL/m2) as evaluated via ventricular end-diastolic volume index augmentation 90 days post Myocardial Infarction (MI)


Enrollment: 253
Study Start Date: September 2003
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PG-116800 tablet
PG-116800 tablet (200 mg) taken twice daily for 90 days
 Drug: PG-116800 (given as PG-530742)
200 mg tablet of PG-116800 (given as PG-530742)twice a day for 90 days
Placebo Comparator: Placebo tablet
Placebo tablet taken twice daily for 90 days
 Drug: Placebo tablet
placebo tablet, twice a day for 90 days

Detailed Description:

Heart attacks cause damage to heart muscle that can weaken the heart and lead to changes in the shape and pumping ability of the heart. These changes can lead to heart failure. An enzyme called metalloproteinase (MMP) plays a role in this damage.

The main purpose of the study is to test whether a possible new drug (called PG-116800) that interferes with the MMP enzyme 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.

This is a Phase II "proof-of-concept" study; that is, it is a first attempt to treat sick people with the drug to see if it works.

The study is interventional since we will be using a drug to interfere with the heart tissue damage that follows a heart attack.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00067236

  Show 52 Study Locations
Sponsors and Collaborators
Procter and Gamble
Investigators
Study Director: Jose Brum, MD Procter and Gamble
  More Information

No publications provided

Responsible Party: Procter and Gamble
ClinicalTrials.gov Identifier: NCT00067236     History of Changes
Other Study ID Numbers: 2002135
Study First Received: August 13, 2003
Results First Received: August 3, 2011
Last Updated: September 27, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cardiomegaly
Heart Failure
Hypertrophy
Infarction
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
 Pathological Conditions, Anatomical
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013