Study of Oral PG-116800 Following a Heart Attack

This study has been completed.

Study NCT00067236 Information provided by Procter and Gamble

First Received on August 13, 2003. Last Updated on September 27, 2011 History of Changes

Results First Received: August 3, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Conditions:	Myocardial Infarction Heart Failure Heart Enlargement
Interventions:	Drug: PG-116800 (given as PG-530742) Drug: Placebo tablet

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo	Placebo tablet twice daily for 90 days
PG-116800 Tablet	PG-116800 tablet (200 mg) twice daily for 90 days

Participant Flow: Overall Study

	Placebo	PG-116800 Tablet
STARTED	128	125
COMPLETED	108	99
NOT COMPLETED	20	26

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Placebo tablet twice daily for 90 days
PG-116800 Tablet	PG-116800 tablet (200 mg) twice daily for 90 days

Baseline Measures

	Placebo	PG-116800 Tablet	Total
Number of Participants [units: participants]	128	125	253
Age [units: years] Mean ± Standard Deviation	59.9 ± 10.22	59.7 ± 11.71	59.8 ± 10.96
Gender [units: participants]
Female	34	32	66
Male	94	93	187
Region of Enrollment [units: participants]
United States	19	16	35
Canada	22	23	45
Poland	87	86	173

Outcome Measures

1. Primary:

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 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Data, calculations, interpretations, opinions, and recommendations will be the property of P&GP. Manuscripts for publication will be drafted by the Expert Panel which will select appropriate journals in which to publish. P&GP, through its Expert Panel representation, will provide technical/editorial/review assistance. Other manuscript(s) will supported as appropriate. These materials must be submitted to P&GP and the Expert Panel for review prior to publication

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Peter Thomas
Organization: Procter & Gamble
phone: 513.622.4838
e-mail: thomas.pr@pg.com

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