Trial Outcomes & Findings for Study of Oral PG-116800 Following a Heart Attack (NCT NCT00067236)
NCT ID: NCT00067236
Last Updated: 2011-11-04
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
253 participants
Primary outcome timeframe
90 days
Results posted on
2011-11-04
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo tablet twice daily for 90 days
|
PG-116800 Tablet
PG-116800 tablet (200 mg) twice daily for 90 days
|
|---|---|---|
|
Overall Study
STARTED
|
128
|
125
|
|
Overall Study
COMPLETED
|
108
|
99
|
|
Overall Study
NOT COMPLETED
|
20
|
26
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Oral PG-116800 Following a Heart Attack
Baseline characteristics by cohort
| Measure |
Placebo
n=128 Participants
Placebo tablet twice daily for 90 days
|
PG-116800 Tablet
n=125 Participants
PG-116800 tablet (200 mg) twice daily for 90 days
|
Total
n=253 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
59.9 years
STANDARD_DEVIATION 10.22 • n=5 Participants
|
59.7 years
STANDARD_DEVIATION 11.71 • n=7 Participants
|
59.8 years
STANDARD_DEVIATION 10.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
187 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
16 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
22 participants
n=5 Participants
|
23 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
87 participants
n=5 Participants
|
86 participants
n=7 Participants
|
173 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: A patient was considered evaluable for the primary efficacy assessment if data were complete for at least the baseline and Day 90 visit (i.e., no data were imputed for the primary endpoint).
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)
Outcome measures
| Measure |
Placebo
n=108 Participants
Placebo tablet twice daily for 90 days
|
PG-116800 Tablet
n=99 Participants
PG-116800 tablet (200 mg) twice daily for 90 days
|
|---|---|---|
|
Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVi in mL/m2) at Day 90 Post Myocardial Infarction (MI)
|
5.48 mL/m2
Standard Error 1.41
|
5.09 mL/m2
Standard Error 1.45
|
Adverse Events
Placebo
Serious events: 67 serious events
Other events: 124 other events
Deaths: 0 deaths
PG-116800 Tablet
Serious events: 75 serious events
Other events: 124 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=128 participants at risk
Placebo tablet twice daily for 90 days
|
PG-116800 Tablet
n=125 participants at risk
PG-116800 tablet (200 mg) twice daily for 90 days
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.78%
1/128 • Number of events 1
|
0.00%
0/125
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.78%
1/128 • Number of events 1
|
0.00%
0/125
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/128
|
0.80%
1/125 • Number of events 1
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/128
|
0.80%
1/125 • Number of events 1
|
|
Cardiac disorders
Bundle branch block
|
0.78%
1/128 • Number of events 1
|
0.00%
0/125
|
|
Cardiac disorders
Intracardiac thrombus
|
0.78%
1/128 • Number of events 1
|
0.00%
0/125
|
|
Cardiac disorders
Coronary Artery disease
|
0.78%
1/128 • Number of events 1
|
0.00%
0/125
|
|
Cardiac disorders
Cardiac failure NOS
|
5.5%
7/128 • Number of events 9
|
2.4%
3/125 • Number of events 5
|
|
Cardiac disorders
Cardiac failure acute
|
0.78%
1/128 • Number of events 1
|
0.00%
0/125
|
|
Cardiac disorders
Cardiac failure chronic
|
0.78%
1/128 • Number of events 1
|
0.00%
0/125
|
|
Cardiac disorders
Cardiac failure congestive
|
1.6%
2/128 • Number of events 2
|
4.8%
6/125 • Number of events 8
|
|
Cardiac disorders
Cardiogenic shock
|
0.78%
1/128 • Number of events 1
|
2.4%
3/125 • Number of events 3
|
|
Cardiac disorders
Acute coronary sydrome
|
2.3%
3/128 • Number of events 3
|
2.4%
3/125 • Number of events 3
|
|
Cardiac disorders
Acute myocardial infarction
|
0.78%
1/128 • Number of events 1
|
1.6%
2/125 • Number of events 2
|
|
Cardiac disorders
Angina pectoris
|
1.6%
2/128 • Number of events 2
|
2.4%
3/125 • Number of events 3
|
|
Cardiac disorders
Angina unstable
|
0.78%
1/128 • Number of events 1
|
1.6%
2/125 • Number of events 2
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/128
|
5.6%
7/125 • Number of events 7
|
|
Cardiac disorders
Myocardial ischaemia
|
0.78%
1/128 • Number of events 1
|
0.00%
0/125
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/128
|
0.80%
1/125 • Number of events 1
|
|
Cardiac disorders
Cardiac aneurysm
|
0.78%
1/128 • Number of events 1
|
0.00%
0/125
|
|
Cardiac disorders
Dressler's syndrome
|
0.78%
1/128 • Number of events 1
|
0.00%
0/125
|
|
Cardiac disorders
Bradycardia
|
0.78%
1/128 • Number of events 1
|
0.00%
0/125
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/128
|
0.80%
1/125 • Number of events 1
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/128
|
0.80%
1/125 • Number of events 1
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/128
|
0.80%
1/125 • Number of events 1
|
|
Cardiac disorders
Ventricular tachycardia
|
0.78%
1/128 • Number of events 1
|
0.00%
0/125
|
|
Ear and labyrinth disorders
Vestibular neruontis
|
0.00%
0/128
|
0.80%
1/125 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/128
|
0.80%
1/125 • Number of events 1
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.78%
1/128 • Number of events 1
|
0.00%
0/125
|
|
General disorders
Asthenia
|
0.00%
0/128
|
0.80%
1/125 • Number of events 1
|
|
General disorders
oedema peripheral
|
0.78%
1/128 • Number of events 1
|
0.80%
1/125 • Number of events 1
|
|
General disorders
Chest pain
|
2.3%
3/128 • Number of events 3
|
1.6%
2/125 • Number of events 2
|
|
General disorders
Discomfort
|
0.78%
1/128 • Number of events 1
|
0.00%
0/125
|
|
General disorders
General disorders and administration site conditions
|
3.9%
5/128 • Number of events 5
|
3.2%
4/125 • Number of events 4
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/128
|
0.80%
1/125 • Number of events 1
|
|
Infections and infestations
Bronchitis acute
|
1.6%
2/128 • Number of events 2
|
0.00%
0/125
|
|
Infections and infestations
Bronchopneumonia
|
1.6%
2/128 • Number of events 2
|
0.00%
0/125
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/128
|
0.80%
1/125 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
1.6%
2/128 • Number of events 2
|
3.2%
4/125 • Number of events 4
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.78%
1/128 • Number of events 1
|
0.00%
0/125
|
|
Investigations
Blood potassium increased
|
0.00%
0/128
|
0.80%
1/125 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
0.00%
0/128
|
0.80%
1/125 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.78%
1/128 • Number of events 1
|
0.00%
0/125
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
0.78%
1/128 • Number of events 1
|
0.00%
0/125
|
|
Musculoskeletal and connective tissue disorders
Intervertebral discitis
|
0.00%
0/128
|
0.80%
1/125 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
0.00%
0/128
|
1.6%
2/125 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
2/128 • Number of events 2
|
0.80%
1/125 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.78%
1/128 • Number of events 1
|
0.80%
1/125 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.00%
0/128
|
0.80%
1/125 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Nodule on extremity
|
0.78%
1/128 • Number of events 1
|
0.00%
0/125
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/128
|
0.80%
1/125 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.78%
1/128 • Number of events 1
|
0.00%
0/125
|
|
Nervous system disorders
Cerebrovascular accident
|
0.78%
1/128 • Number of events 1
|
0.00%
0/125
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/128
|
0.80%
1/125 • Number of events 1
|
|
Nervous system disorders
Transient ischaemic attack
|
0.78%
1/128 • Number of events 1
|
0.80%
1/125 • Number of events 1
|
|
Psychiatric disorders
confusional state
|
0.00%
0/128
|
0.80%
1/125 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
0.78%
1/128 • Number of events 1
|
0.00%
0/125
|
|
Renal and urinary disorders
Renal insufficiency
|
0.78%
1/128 • Number of events 1
|
0.80%
1/125 • Number of events 1
|
|
Reproductive system and breast disorders
Prostatitis
|
0.78%
1/128 • Number of events 1
|
0.00%
0/125
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive airways disease exacerbated
|
0.78%
1/128 • Number of events 1
|
0.00%
0/125
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
0.00%
0/128
|
0.80%
1/125 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.78%
1/128 • Number of events 1
|
0.00%
0/125
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.78%
1/128 • Number of events 1
|
0.00%
0/125
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedemas
|
1.6%
2/128 • Number of events 2
|
0.00%
0/125
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.78%
1/128 • Number of events 1
|
0.80%
1/125 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/128
|
0.80%
1/125 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Face oedema
|
0.00%
0/128
|
0.80%
1/125 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dermatitis medicamentosa
|
0.00%
0/128
|
0.80%
1/125 • Number of events 1
|
|
Vascular disorders
Vascular pesuoaneurysm
|
0.00%
0/128
|
0.80%
1/125 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.78%
1/128 • Number of events 1
|
0.80%
1/125 • Number of events 1
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/128
|
0.80%
1/125 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/128
|
0.80%
1/125 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/128
|
1.6%
2/125 • Number of events 2
|
|
Renal and urinary disorders
Renal failure acute
|
0.78%
1/128 • Number of events 1
|
0.00%
0/125
|
Other adverse events
| Measure |
Placebo
n=128 participants at risk
Placebo tablet twice daily for 90 days
|
PG-116800 Tablet
n=125 participants at risk
PG-116800 tablet (200 mg) twice daily for 90 days
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.7%
6/128 • Number of events 7
|
2.4%
3/125 • Number of events 5
|
|
General disorders
Fatigue
|
7.0%
9/128 • Number of events 10
|
0.00%
0/125
|
|
General disorders
Pyrexia
|
7.0%
9/128 • Number of events 10
|
1.6%
2/125 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.8%
10/128 • Number of events 12
|
13.6%
17/125 • Number of events 29
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
3.1%
4/128 • Number of events 6
|
4.8%
6/125 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/128
|
5.6%
7/125 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.1%
4/128 • Number of events 4
|
4.8%
6/125 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.8%
10/128 • Number of events 12
|
5.6%
7/125 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
2.3%
3/128 • Number of events 3
|
5.6%
7/125 • Number of events 7
|
|
Nervous system disorders
Headache
|
8.6%
11/128 • Number of events 11
|
5.6%
7/125 • Number of events 9
|
|
Nervous system disorders
Dizziness
|
8.6%
11/128 • Number of events 11
|
2.4%
3/125 • Number of events 5
|
|
Nervous system disorders
Anxiety
|
1.6%
2/128 • Number of events 2
|
6.4%
8/125 • Number of events 8
|
|
Nervous system disorders
Insomnia
|
9.4%
12/128 • Number of events 13
|
7.2%
9/125 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.2%
8/128 • Number of events 9
|
8.0%
10/125 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea exertional
|
1.6%
2/128 • Number of events 2
|
5.6%
7/125 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
8/128 • Number of events 9
|
10.4%
13/125 • Number of events 13
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.9%
5/128 • Number of events 5
|
5.6%
7/125 • Number of events 7
|
|
Vascular disorders
Hypertension
|
7.8%
10/128 • Number of events 14
|
4.0%
5/125 • Number of events 5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER