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Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00287729
Recruitment Status : Completed
First Posted : February 7, 2006
Results First Posted : June 13, 2011
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Idiopathic Pulmonary Fibrosis
Interventions Drug: Pirfenidone
Drug: Placebo
Enrollment 344
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pirfenidone (2403 mg/d) Placebo
Hide Arm/Group Description pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day placebo equivalent, given as 3 divided doses 3 times/day
Period Title: Overall Study
Started 171 173
Completed 137 142
Not Completed 34 31
Arm/Group Title Pirfenidone (2403 mg/d) Placebo Total
Hide Arm/Group Description pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day placebo equivalent, given as 3 divided doses 3 times/day Total of all reporting groups
Overall Number of Baseline Participants 171 173 344
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 171 participants 173 participants 344 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
70
  40.9%
61
  35.3%
131
  38.1%
>=65 years
101
  59.1%
112
  64.7%
213
  61.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 171 participants 173 participants 344 participants
66.8  (7.90) 67.0  (7.80) 66.9  (7.84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 171 participants 173 participants 344 participants
Female
48
  28.1%
49
  28.3%
97
  28.2%
Male
123
  71.9%
124
  71.7%
247
  71.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 171 participants 173 participants 344 participants
United States 148 150 298
Europe 23 22 45
Australia 0 1 1
1.Primary Outcome
Title Absolute Change in Percent Predicted Forced Vital Capacity(FVC)
Hide Description Mean Change in Percent Predicted Forced Vital Capacity (FVC) as measured from baseline to week 72. It is calculated as the simple difference between baseline Percent Predicted FVC measurements and week 72 Percent Predicted FVC measurements.
Time Frame Baseline to week 72
Hide Outcome Measure Data
Hide Analysis Population Description
A modified intent-to-treat population of all randomized patients who received any amount of study drug is the primary population for efficacy and safety analyses. Missing FVC data due to death were assigned the worst rank and missing FVC data due to reasons other than death were imputed using the SSD method.
Arm/Group Title Pirfenidone (2403 mg/d) Placebo
Hide Arm/Group Description:
pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
placebo equivalent, given as 3 divided doses 3 times/day
Overall Number of Participants Analyzed 171 173
Mean (Standard Deviation)
Unit of Measure: Change in Percent Predicted FVC
-9  (19.58) -10  (19.12)
2.Secondary Outcome
Title Categorical Assessment of Absolute Change in Percent Predicted Forced Vital Capacity
Hide Description Based on the change in baseline percent predicted FVC at week 72, patients were assigned to 1 of 5 categories: mild decline (<10% but >=0% decline), moderate decline (<20% but >=10% decline), severe decline (>=20% decline), mild improvement (>0% but <10% improvement), or moderate improvement (>=10% improvement). Those who died or had a lung transplant before Week 72 were included in the severe decline category. The results indicate the number of patients who experience Categorical Change in Percent Predicted Forced Vital Capacity.
Time Frame Baseline to week 72
Hide Outcome Measure Data
Hide Analysis Population Description
A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for all efficacy and safety analyses. Missing data were imputed by the SSD method if the patient was alive and imputed to 0% if the patient died before the protocol-specified time point.
Arm/Group Title Pirfenidone (2403 mg/d) Placebo
Hide Arm/Group Description:
pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
placebo equivalent, given as 3 divided doses 3 times/day
Overall Number of Participants Analyzed 171 173
Measure Type: Number
Unit of Measure: Patients
Decline >=20% or death or lung transplantation 20 23
Decline <20% but >= 10% 19 23
Decline <10% but > 0% 88 89
Improvement of >=0% but <10% 41 33
Improvement of >=10% 3 5
3.Secondary Outcome
Title Progression-free Survival
Hide Description Progression is defined as the first occurrence of a 10% absolute decline from baseline in percent predicted Forced Vital Capacity, a 15% absolute decline from baseline in percent predicted hemoglobin(Hgb)-corrected carbon monoxide diffusing capacity (DLco), or, death.
Time Frame Baseline to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses.
Arm/Group Title Pirfenidone (2403 mg/d) Placebo
Hide Arm/Group Description:
pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
placebo equivalent, given as 3 divided doses 3 times/day
Overall Number of Participants Analyzed 171 173
Measure Type: Number
Unit of Measure: Number of Patients with Progression
Death or Disease Progression 54 60
Decline in percent predicted FVC >=10% 31 41
Decline in percent predicted DLco >=15% 10 9
Death Before Disease Progression 13 10
4.Secondary Outcome
Title Change in the Six-Minute Walk Test (6MWT) Distance
Hide Description The change from Baseline to week 72 in distance walked during the 6-Minute Walk Test. This measure was calculated as the simple difference between baseline distanced walked over 6 minutes and week 72 distance walked over 6 minutes as measured in meters (m).
Time Frame Baseline to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses. Missing data were imputed by the SSD method if the patient was alive and imputed to 0 meters if the patient had died before the protocol-specified time point.
Arm/Group Title Pirfenidone (2403 mg/d) Placebo
Hide Arm/Group Description:
pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
placebo equivalent, given as 3 divided doses 3 times/day
Overall Number of Participants Analyzed 171 173
Mean (Standard Deviation)
Unit of Measure: Change in Distance Walked in Meters
-45  (140) -77  (128)
5.Secondary Outcome
Title Change in Worst Oxygen Saturation by Pulse Oximetry (SpO2) Measurement Observed During the 6-Minute Walk Test
Hide Description The change from baseline to week 72 in worst oxygen saturation during the 6-Minute Walk Test as measure by Pulse Oximetry (SpO2) Level. It is calculated as the simple difference between baseline SpO2 measurements and week 72 SpO2 measurements.
Time Frame Baseline to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses. Missing data were imputed by the SSD method if the patient was alive and imputed to 83% if the patient died before the protocol-specified time point.
Arm/Group Title Pirfenidone (2403 mg/d) Placebo
Hide Arm/Group Description:
pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
placebo equivalent, given as 3 divided doses 3 times/day
Overall Number of Participants Analyzed 171 173
Mean (Standard Deviation)
Unit of Measure: Change,Worst Oxygen Saturation (Percent)
-1.9  (3.83) -1.3  (6.63)
6.Secondary Outcome
Title Change in Percent Predicted Hemoglobin (Hb)-Corrected Carbon Monoxide Diffusing Capacity (DLco) of the Lungs
Hide Description The change from baseline to week 72 in Percent Predicted Hemoglobin (Hb)-Corrected Carbon Monoxide Diffusing Capacity (DLco) of the Lungs. It is calculated as the simple difference between baseline DLco measurements and week 72 DLco measurements.
Time Frame Baseline to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses. Missing data were imputed by the SSD method if the patient was alive and imputed to 0% if the patient died before the protocol-specified time point.
Arm/Group Title Pirfenidone (2403 mg/d) Placebo
Hide Arm/Group Description:
pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
placebo equivalent, given as 3 divided doses 3 times/day
Overall Number of Participants Analyzed 171 173
Mean (Standard Deviation)
Unit of Measure: Change in Percent Predicted DLco
-9.8  (12.61) -9.2  (13.24)
7.Secondary Outcome
Title Change in Dyspnea Score
Hide Description The mean change from baseline to week 72 in Dyspnea score was measured by the University of San Diego Shortness of Breath Questionnaire (UCSD SOBQ). The SOBQ is used to assess shortness of breath with various activities of daily living (for example, brushing ones teeth or mowing the lawn). Patients rated the severity of their shortness of breath experienced on an average day during the past week on a 6 point scale (0 to 5),with 0= not at all breathless, 4= severely breathless and 5= Maximally or unable to do because of breathlessness.
Time Frame Baseline to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description

A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses.

Missing data were imputed by the SSD method if the patient was alive and imputed to a score of 120 if the patient died before the protocol-specified time point.

Arm/Group Title Pirfenidone (2403 mg/d) Placebo
Hide Arm/Group Description:
pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
placebo equivalent, given as 3 divided doses 3 times/day
Overall Number of Participants Analyzed 171 173
Mean (Standard Deviation)
Unit of Measure: Change in Dyspnea Score
11.9  (24.72) 13.9  (27.89)
8.Secondary Outcome
Title Worsening of IPF
Hide Description

Worsening of IPF was defined by the occurrence of any of the following events:

Acute IPF exacerbation, IPF-related death, Lung transplantation, or Respiratory hospitalization.

Time Frame Time to acute IPF exacerbation, IPF-related death, lung transplant or respiratory hospitalization, whichever comes first.
Hide Outcome Measure Data
Hide Analysis Population Description
A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses.
Arm/Group Title Pirfenidone (2403 mg/d) Placebo
Hide Arm/Group Description:
pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
placebo equivalent, given as 3 divided doses 3 times/day
Overall Number of Participants Analyzed 171 173
Measure Type: Number
Unit of Measure: Number of Patients Who Worsened
Woresening IPF 24 32
Acute IPF exacerbation 2 1
IPF-related death 3 6
Lung transplantation 2 2
Respiratory hospitalization 17 23
Patients Censored 146 141
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pirfenidone (2403 mg/d) Placebo
Hide Arm/Group Description pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day placebo equivalent, given as 3 divided doses 3 times/day
All-Cause Mortality
Pirfenidone (2403 mg/d) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pirfenidone (2403 mg/d) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   53/171 (30.99%)   51/173 (29.48%) 
Cardiac disorders     
Angina Pectoris  1/171 (0.58%)  1/173 (0.58%) 
Angina Unstable  0/171 (0.00%)  1/173 (0.58%) 
Atrial Fibrillation  2/171 (1.17%)  1/173 (0.58%) 
Cardiac Failure Congestive  1/171 (0.58%)  1/173 (0.58%) 
Coronary Artery Disease  6/171 (3.51%)  0/173 (0.00%) 
Coronary Artery Stenosis  0/171 (0.00%)  1/173 (0.58%) 
Myocardial Infarction  1/171 (0.58%)  0/173 (0.00%) 
Sick Sinus Syndrome  2/171 (1.17%)  0/173 (0.00%) 
Supraventricular Tachycardia  1/171 (0.58%)  0/173 (0.00%) 
Ventricular Tachycardia  1/171 (0.58%)  0/173 (0.00%) 
Gastrointestinal disorders     
Colitis  2/171 (1.17%)  0/173 (0.00%) 
Diverticular Perforation  1/171 (0.58%)  1/173 (0.58%) 
Ileus  0/171 (0.00%)  1/173 (0.58%) 
Pancreatitis  1/171 (0.58%)  0/173 (0.00%) 
General disorders     
Asthenia  0/171 (0.00%)  1/173 (0.58%) 
Chest Pain  1/171 (0.58%)  0/173 (0.00%) 
Multi Organ Failure  1/171 (0.58%)  0/173 (0.00%) 
Non-Cardiac Chest Pain  0/171 (0.00%)  1/173 (0.58%) 
Pyrexia  1/171 (0.58%)  0/173 (0.00%) 
Hepatobiliary disorders     
Cholelithiasis  1/171 (0.58%)  0/173 (0.00%) 
Hepatitis  1/171 (0.58%)  0/173 (0.00%) 
Infections and infestations     
Abdominal Abscess  0/171 (0.00%)  1/173 (0.58%) 
Bronchiectasis  0/171 (0.00%)  1/173 (0.58%) 
Bronchitis  0/171 (0.00%)  5/173 (2.89%) 
Bronchitis Viral  1/171 (0.58%)  0/173 (0.00%) 
Cholecystitis Infective  1/171 (0.58%)  0/173 (0.00%) 
Chronic Sinusitis  1/171 (0.58%)  0/173 (0.00%) 
Clostridium Difficile Colitis  0/171 (0.00%)  1/173 (0.58%) 
Diverticulitis  0/171 (0.00%)  1/173 (0.58%) 
Lobar Pneumonia  7/171 (4.09%)  7/173 (4.05%) 
Pneumonia  1/171 (0.58%)  0/173 (0.00%) 
Respiratory Tract Infection  1/171 (0.58%)  0/173 (0.00%) 
Septic Shock  1/171 (0.58%)  0/173 (0.00%) 
Sinusitis  0/171 (0.00%)  1/173 (0.58%) 
Urinary Tract Infection  1/171 (0.58%)  1/173 (0.58%) 
Viral Infection  0/171 (0.00%)  1/173 (0.58%) 
Viral Upper Respiratory Tract Infection  1/171 (0.58%)  0/173 (0.00%) 
Injury, poisoning and procedural complications     
Ankle Fracture  1/171 (0.58%)  0/173 (0.00%) 
Concussion  0/171 (0.00%)  1/173 (0.58%) 
Endotracheal Intubation Complication  1/171 (0.58%)  0/173 (0.00%) 
Fall  2/171 (1.17%)  1/173 (0.58%) 
Femur Fracture  1/171 (0.58%)  0/173 (0.00%) 
Hip Fracture  2/171 (1.17%)  0/173 (0.00%) 
Psychosis Postoperative  1/171 (0.58%)  0/173 (0.00%) 
Radius Fracture  1/171 (0.58%)  0/173 (0.00%) 
Spinal Compression Fracture  1/171 (0.58%)  0/173 (0.00%) 
Investigations     
Hepatic Enzyme Increased  0/171 (0.00%)  1/173 (0.58%) 
Liver Function Test Abnormal  2/171 (1.17%)  0/173 (0.00%) 
Weight Decreased  0/171 (0.00%)  1/173 (0.58%) 
Metabolism and nutrition disorders     
Pelvic Fracture  1/171 (0.58%)  0/173 (0.00%) 
Dehydration  1/171 (0.58%)  0/173 (0.00%) 
Diabetes Mellitus Inadequate Control  0/171 (0.00%)  1/173 (0.58%) 
Hyperkalaemia  1/171 (0.58%)  0/173 (0.00%) 
Hypoglycaemia  1/171 (0.58%)  0/173 (0.00%) 
Hyponatraemia  1/171 (0.58%)  0/173 (0.00%) 
Musculoskeletal and connective tissue disorders     
Bursitis  1/171 (0.58%)  0/173 (0.00%) 
Intervertebral Disc Protrusion  2/171 (1.17%)  0/173 (0.00%) 
Myalgia  1/171 (0.58%)  0/173 (0.00%) 
Osteoarthritis  0/171 (0.00%)  1/173 (0.58%) 
Pathological Fracture  0/171 (0.00%)  1/173 (0.58%) 
Rotator Cuff Syndrome  0/171 (0.00%)  1/173 (0.58%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder Cancer  1/171 (0.58%)  1/173 (0.58%) 
Bladder Transitional Cell Carcinoma  0/171 (0.00%)  1/173 (0.58%) 
Breast Cancer  0/171 (0.00%)  1/173 (0.58%) 
Colon Cancer Stage II  1/171 (0.58%)  0/173 (0.00%) 
Metastases to Bone  1/171 (0.58%)  0/173 (0.00%) 
Metastases to Lung  1/171 (0.58%)  0/173 (0.00%) 
Metastastic Neoplasm  0/171 (0.00%)  1/173 (0.58%) 
Metastatic Squamous Cell Carcinoma  0/171 (0.00%)  1/173 (0.58%) 
Ovarian Cancer  0/171 (0.00%)  1/173 (0.58%) 
Pancreatic Carcinoma  1/171 (0.58%)  0/173 (0.00%) 
Prostate Cancer  2/171 (1.17%)  0/173 (0.00%) 
Small Cell Lung Cancer Stage Unspecified  1/171 (0.58%)  1/173 (0.58%) 
Squamous Cell Carcinoma  0/171 (0.00%)  1/173 (0.58%) 
Transitional Cell Carcinoma  0/171 (0.00%)  2/173 (1.16%) 
Nervous system disorders     
Apraxia  0/171 (0.00%)  1/173 (0.58%) 
Carotid Artery Stenosis  1/171 (0.58%)  1/173 (0.58%) 
Cerebrovascular Accident  1/171 (0.58%)  0/173 (0.00%) 
Sciatica  0/171 (0.00%)  1/173 (0.58%) 
Transient Ischaemic Attack  0/171 (0.00%)  1/173 (0.58%) 
Psychiatric disorders     
Mental Status Changes  0/171 (0.00%)  1/173 (0.58%) 
Suicidal Ideation  1/171 (0.58%)  0/173 (0.00%) 
Renal and urinary disorders     
Bladder Neck Obstruction  1/171 (0.58%)  0/173 (0.00%) 
Glomerulonephritis Rapidly Progressive  0/171 (0.00%)  1/173 (0.58%) 
Mesangioproliferative Glomerulonephritis  0/171 (0.00%)  1/173 (0.58%) 
Nephrolithiasis  2/171 (1.17%)  0/173 (0.00%) 
Renal Failure Acute  2/171 (1.17%)  2/173 (1.16%) 
Reproductive system and breast disorders     
Benign Prostatic Hyperpasia  0/171 (0.00%)  1/173 (0.58%) 
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Failure  2/171 (1.17%)  3/173 (1.73%) 
Chronic Obstructive Pulmonary Disease  0/171 (0.00%)  1/173 (0.58%) 
Dyspnoea  1/171 (0.58%)  1/173 (0.58%) 
Haemoptysis  0/171 (0.00%)  1/173 (0.58%) 
Hypoxia  0/171 (0.00%)  2/173 (1.16%) 
Idiopathic Pulmonary Fibrosis  13/171 (7.60%)  17/173 (9.83%) 
Pleural Effusion  1/171 (0.58%)  0/173 (0.00%) 
Pneumothorax  1/171 (0.58%)  1/173 (0.58%) 
Productive Cough  1/171 (0.58%)  0/173 (0.00%) 
Respiratory Arrest  0/171 (0.00%)  1/173 (0.58%) 
Respiratory Distress  0/171 (0.00%)  1/173 (0.58%) 
Respiratory Failure  4/171 (2.34%)  6/173 (3.47%) 
Vascular disorders     
Aortic Aneurysm  0/171 (0.00%)  1/173 (0.58%) 
Hypertension  0/171 (0.00%)  2/173 (1.16%) 
Hypotension  2/171 (1.17%)  1/173 (0.58%) 
Malignant Hypertension  1/171 (0.58%)  0/173 (0.00%) 
Thrombosis  1/171 (0.58%)  0/173 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pirfenidone (2403 mg/d) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   169/171 (98.83%)   170/173 (98.27%) 
Metabolism and nutrition disorders     
Anorexia   18/171 (10.53%)  6/173 (3.47%) 
Decreased appetite   13/171 (7.60%)  9/173 (5.20%) 
Musculoskeletal and connective tissue disorders     
Arthralgia   16/171 (9.36%)  11/173 (6.36%) 
Back Pain   21/171 (12.28%)  15/173 (8.67%) 
Musculoskeletal Pain   6/171 (3.51%)  9/173 (5.20%) 
Pain in Extremity   11/171 (6.43%)  11/173 (6.36%) 
Nervous system disorders     
Dizziness   30/171 (17.54%)  18/173 (10.40%) 
Headache   28/171 (16.37%)  25/173 (14.45%) 
Psychiatric disorders     
Anxiety   6/171 (3.51%)  10/173 (5.78%) 
Depression   10/171 (5.85%)  7/173 (4.05%) 
Insomnia   12/171 (7.02%)  11/173 (6.36%) 
Respiratory, thoracic and mediastinal disorders     
Cough   51/171 (29.82%)  54/173 (31.21%) 
Dyspnoea   28/171 (16.37%)  34/173 (19.65%) 
Idiopathic Pulmonary Fibrosis   31/171 (18.13%)  40/173 (23.12%) 
Nasal Congestion   12/171 (7.02%)  14/173 (8.09%) 
Pharyngolaryngeal pain   8/171 (4.68%)  11/173 (6.36%) 
Postnasal Drip   7/171 (4.09%)  12/173 (6.94%) 
Productive Cough   11/171 (6.43%)  3/173 (1.73%) 
Respiratory Failure   5/171 (2.92%)  8/173 (4.62%) 
Rhinitis Allergic   11/171 (6.43%)  4/173 (2.31%) 
Skin and subcutaneous tissue disorders     
Photosensitivity reaction   17/171 (9.94%)  4/173 (2.31%) 
Pruritus   10/171 (5.85%)  8/173 (4.62%) 
Rash   58/171 (33.92%)  22/173 (12.72%) 
Indicates events were collected by systematic assessment
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.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bill Bradford, MD, PhD
Organization: InterMune, Inc.
Phone: (415) 466-2200
EMail: bbradford@intermune.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00287729     History of Changes
Other Study ID Numbers: PIPF-006
Capacity 1
First Submitted: February 6, 2006
First Posted: February 7, 2006
Results First Submitted: June 2, 2010
Results First Posted: June 13, 2011
Last Update Posted: April 17, 2017