Myocardial InfarctionPhase 2NCT00067236
Study of Oral PG-116800 Following a Heart Attack
A Phase 2 study testing PG-116800 (given as PG-530742) in people with Myocardial Infarction and Heart Failure, run by Procter and Gamble at 52 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Infarction, Heart Failure, Heart Enlargement
- What is being tested?
- PG-116800 (given as PG-530742)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 253 participants
- Where
- 52 sitesin 3 countries
- Study dates
- Sep 2003to Dec 2004
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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.
Trial locations and contacts
52 sites in 3 countries.
52 sites in 3 countries
United States21 sites
Piedmont Hospital
Atlanta, Georgia, 30309
JFK Medical Center
Atlantis, Florida, 33462
Medical University of South Carolina
Charleston, South Carolina, 29403
Presbyterian Hospital
Charlotte, North Carolina, 28204
Memorial Hospital
Chattanooga, Tennessee, 37404-1127
Morton Plant Hospital
Clearwater, Florida, 33756
Porter Adventist Hospital
Denver, Colorado, 80210
Henry Ford Hospital
Detroit, Michigan, 48202
University of Connecticut Health Center
Farmington, Connecticut, 06030-2202
Moses Cone Hospital
Greensboro, North Carolina, 27401
Westmoreland Regional Hospital
Greensburg, Pennsylvania, 15601-2745
Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Memorial Hermann Hospital
Houston, Texas, 77030
University of Arkansas for Medical Sciences and Central Arkansas Veterans Health Care System
Little Rock, Arkansas, 72205
Mercy Community Medical Center
Merced, California, 95340
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407-1139
West Virginia University Hospital
Morgantown, West Virginia, 26506-9157
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120
Rhode Island Hospital
Providence, Rhode Island, 02903
Strong Memorial Hospital
Rochester, New York, 14642
Barnes Jewish Hospital
St Louis, Missouri, 63110
Canada19 sites
Foothills Hospital
Calgary, Alberta, T2N 4N1
Alder Medical Centre
Campbell River, British Columbia, V9W 5Y4
Royal Alexandra Hospital
Edmonton, Alberta, T5G 3C8
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Grey Nuns Hospital
Edmonton, Alberta, T6L 5X8
CHUS, Hopital Fleurimont
Fleurimont, Quebec, J1H 5N4
Queen Elizabeth II HSC
Halifax, Nova Scotia, B3H 3H7
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
McGill University Health Centre, Royal Victoria Hospital
Montreal, Quebec, H3A 1A1
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Hopital Sacre-Coeur
Montreal, Quebec, H4J 1C5
Southlake Regional HC
Newmarket, Ontario, L3Y 2R2
St. John's HSC
Saint John's, New Brunswick, A1B 3V6
Scarborough Grace Hospital
Scarborough Village, Ontario, M1S 4V5
Hopital Laval
Ste-Foy, Quebec, G1V 4G5
Toronto East General
Toronto, Ontario, M4C 3E7
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Vancouver General Hospital
Vancouver, British Columbia, V5Z 4E3
Victoria Heart Institute
Victoria, British Columbia, V8R 4R2
Poland12 sites
Klinika Kardiologii, Panstwowy Szpital Kliniczny
Bialystok, Bialystok
Katedra i Klinika Kardiologii i Chorob Wewnetznych, Akademia Medyczna w Bydgoszczy
Bydgoszcz, Bydgoszcz
1 Katedra Kardiologii Slaskiej Akademii Medycznej
Katowice, Katowice
Klinika Chorob Serca i Naczyn, Krakowski Szpital Specjalistyczny
Krakow, Krakow
Oddzial Kardiologii, Wojewodzki Szpital Specjalistyczny
Krakow, Krakow
Klinika Kardiologii IMW, Uniwersytet Medyczny w Lodzi
Lodz, Łódź Voivodeship
I Klinika Kardilogii Akademii Medycznej w Poznaniu
Poznan, Poznan
Oddzial Internistyczno-Kardiologiczny, Samodzieiny Publiczny Wojewodzki Szpital Zespolony
Szczecin, Szczecin
I Klinika Choroby Wiencowej, Instytut Kardiologii w Warszawie
Warsaw, Warszawa
Klinika Choroby Wiencowej, Instytut Kardiologi w Warszawie
Warsaw, Warszawa
Klinika Kardilogii Inwazyjnej, Centrainy Szpital MSWiA
Warsaw, Warszawa
Klinika Kardiologii, Szpital Grochowski
Warsaw, Warszawa
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral PG-116800 Following a Heart Attack
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.
Read the 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.
- Conditions
- Myocardial Infarction, Heart Failure, Heart Enlargement
- Being tested
- PG-116800 (given as PG-530742), Placebo tablet
- Medical subject headings
- Myocardial Infarction, Heart Failure, Cardiomegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| PG-116800 tablet | Experimental | PG-116800 tablet (200 mg) taken twice daily for 90 days Receives: Drug: PG-116800 (given as PG-530742) |
| Placebo tablet | Placebo comparator | Placebo tablet taken twice daily for 90 days Receives: Drug: Placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVi in mL/m2) at Day 90 Post Myocardial Infarction (MI)
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)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2003 (estimated)
- Study startSep 2003
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose Brum, MD, Study director, Procter and Gamble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00067236
- Sponsor's protocol ID
- 2002135
- Status last verified
- Sep 2011
- First submitted
- 13 Aug 2003
- Last updated
- 4 Nov 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral PG-116800 Following a Heart Attack
- ClinicalTrials.gov ID
- NCT00067236
- Acronym / sponsor ID
- 2002135
- Conditions
- Myocardial Infarction, Heart Failure, Heart Enlargement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 14 Aug 2003 (estimated)
- Results
- Posted 4 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PG-116800 tablet | Experimental | Drug: PG-116800 (given as PG-530742)PG-116800 tablet (200 mg) taken twice daily for 90 days |
| Placebo tablet | Placebo comparator | Drug: Placebo tabletPlacebo tablet taken twice daily for 90 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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%.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PG-116800 (given as PG-530742)200 mg tablet of PG-116800 (given as PG-530742)twice a day for 90 days | Drug | PG-116800 tablet |
| Placebo tabletplacebo tablet, twice a day for 90 days | Drug | Placebo tablet |
Primary outcome
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Brum, MD study director
Procter and Gamble
52 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PG-116800 (given as PG-530742) in people with Myocardial Infarction and Heart Failure, run by Procter and Gamble at 52 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in United States, Canada, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2011.