Study of Oral PG-116800 Following a Heart Attack - Full Text View

Sponsored by:	Procter and Gamble
Information provided by:	Procter and Gamble
ClinicalTrials.gov Identifier:	NCT00067236

Purpose

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.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral PG-116800 Following a Heart Attack

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack Heart Failure

Drug Information available for: PG 116800

U.S. FDA Resources

Further study details as provided by Procter and Gamble:

Primary Outcome Measures:

Prevented left ventricular end-diastolic volume index augmentation 90 days post MI [ Time Frame: 90 days ] [ Designated as safety issue: No ]

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
1: Placebo Comparator Placebo tablet twice daily for 90 days	Drug: Placebo tablet placebo tablet, twice a day for 90 days
2: Experimental PG-116800 tablet (200 mg) 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

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 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 Pharmaceuticals ( Jose Brum, MD )
Study ID Numbers:	2002135
Study First Received:	August 13, 2003
Last Updated:	February 11, 2008
ClinicalTrials.gov Identifier:	NCT00067236 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Necrosis
Hypertrophy
Heart Failure
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Ischemia
Infarction
Cardiomegaly
Myocardial Infarction

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Heart Failure
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia
Hypertrophy

Necrosis
Pathologic Processes
Cardiovascular Diseases
Infarction
Cardiomegaly
Myocardial Infarction

ClinicalTrials.gov processed this record on July 02, 2009