Study of Oral PG-116800 Following a Heart Attack
Sponsor
Procter and Gamble (Industry)
Overall Status
Completed
CT.gov ID
NCT00067236
Collaborator
(none)
253
52
2
15
4.9
0.3
Study Details
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 |
|---|---|---|
|
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
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
:
Sep 1, 2003
Actual Primary Completion Date
:
Dec 1, 2004
Actual Study Completion Date
:
Dec 1, 2004
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
- Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVi in mL/m2) at Day 90 Post Myocardial Infarction (MI) [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
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Arkansas for Medical Sciences and Central Arkansas Veterans Health Care System | Little Rock | Arkansas | United States | 72205 |
| 2 | Mercy Community Medical Center | Merced | California | United States | 95340 |
| 3 | Porter Adventist Hospital | Denver | Colorado | United States | 80210 |
| 4 | University of Connecticut Health Center | Farmington | Connecticut | United States | 06030-2202 |
| 5 | JFK Medical Center | Atlantis | Florida | United States | 33462 |
| 6 | Morton Plant Hospital | Clearwater | Florida | United States | 33756 |
| 7 | Piedmont Hospital | Atlanta | Georgia | United States | 30309 |
| 8 | Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
| 9 | Abbott-Northwestern Hospital | Minneapolis | Minnesota | United States | 55407-1139 |
| 10 | Barnes Jewish Hospital | St. Louis | Missouri | United States | 63110 |
| 11 | Strong Memorial Hospital | Rochester | New York | United States | 14642 |
| 12 | Presbyterian Hospital | Charlotte | North Carolina | United States | 28204 |
| 13 | Moses Cone Hospital | Greensboro | North Carolina | United States | 27401 |
| 14 | Oklahoma Heart Hospital | Oklahoma City | Oklahoma | United States | 73120 |
| 15 | Westmoreland Regional Hospital | Greensburg | Pennsylvania | United States | 15601-2745 |
| 16 | Hershey Medical Center | Hershey | Pennsylvania | United States | 17033-0850 |
| 17 | Rhode Island Hospital | Providence | Rhode Island | United States | 02903 |
| 18 | Medical University of South Carolina | Charleston | South Carolina | United States | 29403 |
| 19 | Memorial Hospital | Chattanooga | Tennessee | United States | 37404-1127 |
| 20 | Memorial Hermann Hospital | Houston | Texas | United States | 77030 |
| 21 | West Virginia University Hospital | Morgantown | West Virginia | United States | 26506-9157 |
| 22 | Foothills Hospital | Calgary | Alberta | Canada | T2N 4N1 |
| 23 | Royal Alexandra Hospital | Edmonton | Alberta | Canada | T5G 3C8 |
| 24 | University of Alberta Hospital | Edmonton | Alberta | Canada | T6G 2B7 |
| 25 | Grey Nuns Hospital | Edmonton | Alberta | Canada | T6L 5X8 |
| 26 | Alder Medical Centre | Campbell River | British Columbia | Canada | V9W 5Y4 |
| 27 | Vancouver General Hospital | Vancouver | British Columbia | Canada | V5Z 4E3 |
| 28 | Victoria Heart Institute | Victoria | British Columbia | Canada | V8R 4R2 |
| 29 | St. John's HSC | St. John's | New Brunswick | Canada | A1B 3V6 |
| 30 | Queen Elizabeth II HSC | Halifax | Nova Scotia | Canada | B3H 3H7 |
| 31 | Southlake Regional HC | Newmarket | Ontario | Canada | L3Y 2R2 |
| 32 | Scarborough Grace Hospital | Scarborough | Ontario | Canada | M1S 4V5 |
| 33 | Toronto East General | Toronto | Ontario | Canada | M4C 3E7 |
| 34 | St. Michael's Hospital | Toronto | Ontario | Canada | M5B 1W8 |
| 35 | CHUS, Hopital Fleurimont | Fleurimont | Quebec | Canada | J1H 5N4 |
| 36 | Montreal Heart Institute | Montreal | Quebec | Canada | H1T 1C8 |
| 37 | McGill University Health Centre, Royal Victoria Hospital | Montreal | Quebec | Canada | H3A 1A1 |
| 38 | Montreal General Hospital | Montreal | Quebec | Canada | H3G 1A4 |
| 39 | Hopital Sacre-Coeur | Montreal | Quebec | Canada | H4J 1C5 |
| 40 | Hopital Laval | Ste-Foy | Quebec | Canada | G1V 4G5 |
| 41 | Klinika Kardiologii, Panstwowy Szpital Kliniczny | Bialystok | Poland | ||
| 42 | Katedra i Klinika Kardiologii i Chorob Wewnetznych, Akademia Medyczna w Bydgoszczy | Bydgoszcz | Poland | ||
| 43 | 1 Katedra Kardiologii Slaskiej Akademii Medycznej | Katowice | Poland | ||
| 44 | Klinika Chorob Serca i Naczyn, Krakowski Szpital Specjalistyczny | Krakow | Poland | ||
| 45 | Oddzial Kardiologii, Wojewodzki Szpital Specjalistyczny | Krakow | Poland | ||
| 46 | Klinika Kardiologii IMW, Uniwersytet Medyczny w Lodzi | Lodz | Poland | ||
| 47 | I Klinika Kardilogii Akademii Medycznej w Poznaniu | Poznan | Poland | ||
| 48 | Oddzial Internistyczno-Kardiologiczny, Samodzieiny Publiczny Wojewodzki Szpital Zespolony | Szczecin | Poland | ||
| 49 | I Klinika Choroby Wiencowej, Instytut Kardiologii w Warszawie | Warszawa | Poland | ||
| 50 | Klinika Choroby Wiencowej, Instytut Kardiologi w Warszawie | Warszawa | Poland | ||
| 51 | Klinika Kardilogii Inwazyjnej, Centrainy Szpital MSWiA | Warszawa | Poland | ||
| 52 | Klinika Kardiologii, Szpital Grochowski | Warszawa | Poland |
Sponsors and Collaborators
- Procter and Gamble
Investigators
- Study Director: Jose Brum, MD, Procter and Gamble
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Procter and Gamble
ClinicalTrials.gov Identifier:
NCT00067236
Other Study ID Numbers:
- 2002135
First Posted:
Aug 14, 2003
Last Update Posted:
Nov 4, 2011
Last Verified:
Sep 1, 2011
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Placebo | PG-116800 Tablet |
|---|---|---|
| Arm/Group Description | Placebo tablet twice daily for 90 days | PG-116800 tablet (200 mg) twice daily for 90 days |
| Period Title: Overall Study | ||
| STARTED | 128 | 125 |
| COMPLETED | 108 | 99 |
| NOT COMPLETED | 20 | 26 |
Baseline Characteristics
| Arm/Group Title | Placebo | PG-116800 Tablet | Total |
|---|---|---|---|
| Arm/Group Description | Placebo tablet twice daily for 90 days | PG-116800 tablet (200 mg) twice daily for 90 days | Total of all reporting groups |
| Overall Participants | 128 | 125 | 253 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
59.9
(10.22)
|
59.7
(11.71)
|
59.8
(10.96)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
34
26.6%
|
32
25.6%
|
66
26.1%
|
| Male |
94
73.4%
|
93
74.4%
|
187
73.9%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
19
14.8%
|
16
12.8%
|
35
13.8%
|
| Canada |
22
17.2%
|
23
18.4%
|
45
17.8%
|
| Poland |
87
68%
|
86
68.8%
|
173
68.4%
|
Outcome Measures
| Title | Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVi in mL/m2) at Day 90 Post Myocardial Infarction (MI) |
|---|---|
| Description | 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) |
| Time Frame | 90 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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). |
| Arm/Group Title | Placebo | PG-116800 Tablet |
|---|---|---|
| Arm/Group Description | Placebo tablet twice daily for 90 days | PG-116800 tablet (200 mg) twice daily for 90 days |
| Measure Participants | 108 | 99 |
| Mean (Standard Error) [mL/m2] |
5.48
(1.41)
|
5.09
(1.45)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PG-116800 Tablet |
|---|---|---|
| Comments | Changes from baseline in efficacy parameters at Day 90. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4239 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 4 | |
| Confidence Interval |
(2-Sided) 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Placebo | PG-116800 Tablet | ||
| Arm/Group Description | Placebo tablet twice daily for 90 days | PG-116800 tablet (200 mg) twice daily for 90 days | ||
All Cause Mortality |
||||
| Placebo | PG-116800 Tablet | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Placebo | PG-116800 Tablet | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 67/128 (52.3%) | 75/125 (60%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 1/128 (0.8%) | 1 | 0/125 (0%) | 0 |
| Pancytopenia | 1/128 (0.8%) | 1 | 0/125 (0%) | 0 |
| Cardiac disorders | ||||
| Atrioventricular block complete | 0/128 (0%) | 0 | 1/125 (0.8%) | 1 |
| Atrioventricular block second degree | 0/128 (0%) | 0 | 1/125 (0.8%) | 1 |
| Bundle branch block | 1/128 (0.8%) | 1 | 0/125 (0%) | 0 |
| Intracardiac thrombus | 1/128 (0.8%) | 1 | 0/125 (0%) | 0 |
| Coronary Artery disease | 1/128 (0.8%) | 1 | 0/125 (0%) | 0 |
| Cardiac failure NOS | 7/128 (5.5%) | 9 | 3/125 (2.4%) | 5 |
| Cardiac failure acute | 1/128 (0.8%) | 1 | 0/125 (0%) | 0 |
| Cardiac failure chronic | 1/128 (0.8%) | 1 | 0/125 (0%) | 0 |
| Cardiac failure congestive | 2/128 (1.6%) | 2 | 6/125 (4.8%) | 8 |
| Cardiogenic shock | 1/128 (0.8%) | 1 | 3/125 (2.4%) | 3 |
| Acute coronary sydrome | 3/128 (2.3%) | 3 | 3/125 (2.4%) | 3 |
| Acute myocardial infarction | 1/128 (0.8%) | 1 | 2/125 (1.6%) | 2 |
| Angina pectoris | 2/128 (1.6%) | 2 | 3/125 (2.4%) | 3 |
| Angina unstable | 1/128 (0.8%) | 1 | 2/125 (1.6%) | 2 |
| Myocardial infarction | 0/128 (0%) | 0 | 7/125 (5.6%) | 7 |
| Myocardial ischaemia | 1/128 (0.8%) | 1 | 0/125 (0%) | 0 |
| Mitral valve incompetence | 0/128 (0%) | 0 | 1/125 (0.8%) | 1 |
| Cardiac aneurysm | 1/128 (0.8%) | 1 | 0/125 (0%) | 0 |
| Dressler's syndrome | 1/128 (0.8%) | 1 | 0/125 (0%) | 0 |
| Bradycardia | 1/128 (0.8%) | 1 | 0/125 (0%) | 0 |
| Atrial fibrillation | 0/128 (0%) | 0 | 1/125 (0.8%) | 1 |
| Tricuspid valve incompetence | 0/128 (0%) | 0 | 1/125 (0.8%) | 1 |
| Ventricular fibrillation | 0/128 (0%) | 0 | 1/125 (0.8%) | 1 |
| Ventricular tachycardia | 1/128 (0.8%) | 1 | 0/125 (0%) | 0 |
| Cardiac arrest | 0/128 (0%) | 0 | 1/125 (0.8%) | 1 |
| Ear and labyrinth disorders | ||||
| Vestibular neruontis | 0/128 (0%) | 0 | 1/125 (0.8%) | 1 |
| Gastrointestinal disorders | ||||
| Gastritis | 0/128 (0%) | 0 | 1/125 (0.8%) | 1 |
| Diverticular perforation | 1/128 (0.8%) | 1 | 0/125 (0%) | 0 |
| General disorders | ||||
| Asthenia | 0/128 (0%) | 0 | 1/125 (0.8%) | 1 |
| oedema peripheral | 1/128 (0.8%) | 1 | 1/125 (0.8%) | 1 |
| Chest pain | 3/128 (2.3%) | 3 | 2/125 (1.6%) | 2 |
| Discomfort | 1/128 (0.8%) | 1 | 0/125 (0%) | 0 |
| General disorders and administration site conditions | 5/128 (3.9%) | 5 | 4/125 (3.2%) | 4 |
| Hepatobiliary disorders | ||||
| Hepatic failure | 0/128 (0%) | 0 | 1/125 (0.8%) | 1 |
| Infections and infestations | ||||
| Bronchitis acute | 2/128 (1.6%) | 2 | 0/125 (0%) | 0 |
| Bronchopneumonia | 2/128 (1.6%) | 2 | 0/125 (0%) | 0 |
| Lower respiratory tract infection | 0/128 (0%) | 0 | 1/125 (0.8%) | 1 |
| Pneumonia | 2/128 (1.6%) | 2 | 4/125 (3.2%) | 4 |
| Injury, poisoning and procedural complications | ||||
| Coronary artery restenosis | 1/128 (0.8%) | 1 | 0/125 (0%) | 0 |
| Investigations | ||||
| Blood potassium increased | 0/128 (0%) | 0 | 1/125 (0.8%) | 1 |
| Blood creatinine increased | 0/128 (0%) | 0 | 1/125 (0.8%) | 1 |
| Metabolism and nutrition disorders | ||||
| Diabetic ketoacidosis | 1/128 (0.8%) | 1 | 0/125 (0%) | 0 |
| Metabolism and nutrition disorders | 1/128 (0.8%) | 1 | 0/125 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Intervertebral discitis | 0/128 (0%) | 0 | 1/125 (0.8%) | 1 |
| Joint contracture | 0/128 (0%) | 0 | 2/125 (1.6%) | 2 |
| Arthralgia | 2/128 (1.6%) | 2 | 1/125 (0.8%) | 1 |
| Joint range of motion decreased | 1/128 (0.8%) | 1 | 1/125 (0.8%) | 1 |
| Fasciitis | 0/128 (0%) | 0 | 1/125 (0.8%) | 1 |
| Nodule on extremity | 1/128 (0.8%) | 1 | 0/125 (0%) | 0 |
| Tendonitis | 0/128 (0%) | 0 | 1/125 (0.8%) | 1 |
| Musculoskeletal chest pain | 0/128 (0%) | 0 | 1/125 (0.8%) | 1 |
| Tendon disorder | 0/128 (0%) | 0 | 2/125 (1.6%) | 2 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Rectal cancer | 1/128 (0.8%) | 1 | 0/125 (0%) | 0 |
| Nervous system disorders | ||||
| Cerebrovascular accident | 1/128 (0.8%) | 1 | 0/125 (0%) | 0 |
| Syncope vasovagal | 0/128 (0%) | 0 | 1/125 (0.8%) | 1 |
| Transient ischaemic attack | 1/128 (0.8%) | 1 | 1/125 (0.8%) | 1 |
| Psychiatric disorders | ||||
| confusional state | 0/128 (0%) | 0 | 1/125 (0.8%) | 1 |
| Renal and urinary disorders | ||||
| Urinary retention | 1/128 (0.8%) | 1 | 0/125 (0%) | 0 |
| Renal insufficiency | 1/128 (0.8%) | 1 | 1/125 (0.8%) | 1 |
| Renal failure acute | 1/128 (0.8%) | 1 | 0/125 (0%) | 0 |
| Reproductive system and breast disorders | ||||
| Prostatitis | 1/128 (0.8%) | 1 | 0/125 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Chronic obstructive airways disease exacerbated | 1/128 (0.8%) | 1 | 0/125 (0%) | 0 |
| epistaxis | 0/128 (0%) | 0 | 1/125 (0.8%) | 1 |
| Pneumothorax | 1/128 (0.8%) | 1 | 0/125 (0%) | 0 |
| Pulmonary hypertension | 1/128 (0.8%) | 1 | 0/125 (0%) | 0 |
| Pulmonary oedemas | 2/128 (1.6%) | 2 | 0/125 (0%) | 0 |
| Pulmonary embolism | 1/128 (0.8%) | 1 | 1/125 (0.8%) | 1 |
| Acute respiratory failure | 0/128 (0%) | 0 | 1/125 (0.8%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| Face oedema | 0/128 (0%) | 0 | 1/125 (0.8%) | 2 |
| Dermatitis medicamentosa | 0/128 (0%) | 0 | 1/125 (0.8%) | 1 |
| Vascular disorders | ||||
| Vascular pesuoaneurysm | 0/128 (0%) | 0 | 1/125 (0.8%) | 1 |
| Hypotension | 1/128 (0.8%) | 1 | 1/125 (0.8%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Placebo | PG-116800 Tablet | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 124/128 (96.9%) | 124/125 (99.2%) | ||
| Gastrointestinal disorders | ||||
| Nausea | 6/128 (4.7%) | 7 | 3/125 (2.4%) | 5 |
| General disorders | ||||
| Fatigue | 9/128 (7%) | 10 | 0/125 (0%) | 0 |
| Pyrexia | 9/128 (7%) | 10 | 2/125 (1.6%) | 3 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 10/128 (7.8%) | 12 | 17/125 (13.6%) | 29 |
| Joint range of motion decreased | 4/128 (3.1%) | 6 | 6/125 (4.8%) | 7 |
| Joint stiffness | 0/128 (0%) | 0 | 7/125 (5.6%) | 10 |
| Back pain | 4/128 (3.1%) | 4 | 6/125 (4.8%) | 7 |
| Pain in extremity | 10/128 (7.8%) | 12 | 7/125 (5.6%) | 10 |
| Tendon disorder | 3/128 (2.3%) | 3 | 7/125 (5.6%) | 7 |
| Nervous system disorders | ||||
| Headache | 11/128 (8.6%) | 11 | 7/125 (5.6%) | 9 |
| Dizziness | 11/128 (8.6%) | 11 | 3/125 (2.4%) | 5 |
| Anxiety | 2/128 (1.6%) | 2 | 8/125 (6.4%) | 8 |
| Insomnia | 12/128 (9.4%) | 13 | 9/125 (7.2%) | 9 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspnea | 8/128 (6.3%) | 9 | 10/125 (8%) | 10 |
| Dyspnea exertional | 2/128 (1.6%) | 2 | 7/125 (5.6%) | 7 |
| Cough | 8/128 (6.3%) | 9 | 13/125 (10.4%) | 13 |
| Skin and subcutaneous tissue disorders | ||||
| Rash | 5/128 (3.9%) | 5 | 7/125 (5.6%) | 7 |
| Vascular disorders | ||||
| Hypertension | 10/128 (7.8%) | 14 | 5/125 (4%) | 5 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
Results Point of Contact
| Name/Title | Peter Thomas |
|---|---|
| Organization | Procter & Gamble |
| Phone | 513.622.4838 |
| thomas.pr@pg.com |
Responsible Party:
Procter and Gamble
ClinicalTrials.gov Identifier:
NCT00067236
Other Study ID Numbers:
- 2002135
First Posted:
Aug 14, 2003
Last Update Posted:
Nov 4, 2011
Last Verified:
Sep 1, 2011