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Study of Oral PG-116800 Following a Heart Attack

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00067236
Recruitment Status : Completed
First Posted : August 14, 2003
Results First Posted : November 4, 2011
Last Update Posted : November 4, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

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

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 253 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral PG-116800 Following a Heart Attack
Study Start Date : September 2003
Primary Completion Date : December 2004
Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    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)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00067236


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

Responsible Party: Procter and Gamble
ClinicalTrials.gov Identifier: NCT00067236     History of Changes
Other Study ID Numbers: 2002135
First Posted: August 14, 2003    Key Record Dates
Results First Posted: November 4, 2011
Last Update Posted: November 4, 2011
Last Verified: September 2011

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