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Trial record 84 of 382 for:    IFNA2 AND RBV AND genotype

A Phase 1 Study of MP-424, Peginterferon Alfa 2b, and Ribavirin in Hepatitis C

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ClinicalTrials.gov Identifier: NCT00630058
Recruitment Status : Completed
First Posted : March 6, 2008
Results First Posted : January 18, 2013
Last Update Posted : May 2, 2014
Sponsor:
Collaborator:
Vertex Pharmaceuticals Incorporated
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition Hepatitis C
Interventions Drug: MP-424(H), PEG-IFN-a-2b, RBV
Drug: MP-424 (L), PEG-IFN-a-2b, RBV
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group A (MP-424 High) Group B (MP-424 Low)
Hide Arm/Group Description

Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir

Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks

Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks

Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir

Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks

Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks

Period Title: Overall Study
Started 10 10
Completed 6 6
Not Completed 4 4
Reason Not Completed
Adverse Event             1             1
Withdrawal by Subject             0             1
stopping criteria             3             2
Arm/Group Title Group A (MP-424 High) Group B (MP-424 Low) Total
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Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir

Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks

Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks

Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir

Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks

Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks

Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
50.1  (6.8) 54.3  (8.5) 52.2  (7.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
4
  40.0%
6
  60.0%
10
  50.0%
Male
6
  60.0%
4
  40.0%
10
  50.0%
1.Primary Outcome
Title Cmax (Maximum Observed Concentration in Plasma) of MP-424
Hide Description

Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.

Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.

Time Frame Data were collected at Day1 to Day85
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A (MP-424 High) Group B (MP-424 Low)
Hide Arm/Group Description:

Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir

Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks

Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks

Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir

Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks

Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: μg/mL
Day 1 (Group A,B:10 cases) 1.62  (0.43) 1.45  (0.83)
Day 14 (Group A,B:10 cases) 3.96  (1.10) 3.06  (0.90)
Day 85 (Group A: 6 cases, Group B: 7 cases) 3.67  (0.87) 3.16  (1.10)
2.Primary Outcome
Title Tmax (Time of Maximum Concentration in Plasma) of MP-424
Hide Description

Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.

Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.

Time Frame Data were collected at Day1 to Day85
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A (MP-424 High) Group B (MP-424 Low)
Hide Arm/Group Description:

Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir

Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks

Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks

Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir

Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks

Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks

Overall Number of Participants Analyzed 10 10
Median (Full Range)
Unit of Measure: hours
Day 1 (Group A, B:10 cases)
2.51
(2.25 to 6.00)
2.54
(2.33 to 8.02)
Day 14 (Group A, B:10 cases)
2.50
(2.42 to 5.75)
2.45
(2.33 to 6.00)
Day 85 (Group A: 6 cases, Group B: 7 cases)
3.24
(2.35 to 7.75)
2.43
(2.33 to 4.00)
3.Primary Outcome
Title AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424
Hide Description

Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.

Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.

Time Frame Data were collected at Day1 to Day85
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A (MP-424 High) Group B (MP-424 Low)
Hide Arm/Group Description:

Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir

Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks

Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks

Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir

Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks

Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: μg/mL
Day 1 (Group A, B: 10 cases) 7.53  (1.93) 6.55  (3.73)
Day 14 (Group A: 9 cases, Group B: 10 cases) 26.00  (6.77) 19.94  (5.97)
Day 85 (Group A: 6 cases, Group B: 7 cases) 25.00  (5.23) 21.35  (6.88)
4.Primary Outcome
Title Ctrough (Minimum Observed Concentration in Plasma) of MP-424
Hide Description

Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.

Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.

Time Frame Data were collected at Day1 to Day85
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A (MP-424 High) Group B (MP-424 Low)
Hide Arm/Group Description:

Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir

Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks

Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks

Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir

Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks

Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: μg/mL
Day1 (Group A,B: 10 cases) 0.846  (0.500) 0.681  (0.412)
Day14 (Group A: 9 cases, Group B:10cases) 2.639  (0.556) 1.914  (0.717)
Day85 (Group A: 6 cases, Group B:7cases) 2.679  (0.355) 2.105  (0.819)
5.Primary Outcome
Title T1/2(Time of Half-Life) of MP-424
Hide Description

Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.

Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.

Time Frame Data were collected at Day1 to Day85
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A (MP-424 High) Group B (MP-424 Low)
Hide Arm/Group Description:

Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir

Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks

Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks

Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir

Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks

Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: hours
Day1 (Group A: 7 cases, Group B: 8 cases) 4.87  (2.12) 4.03  (1.63)
Day14 (Group A: 8 cases, Group B: 9 cases) 9.99  (4.37) 10.00  (6.97)
Day85 (Group A: 6 cases, Group B: 7 cases) 9.06  (3.98) 6.22  (3.64)
6.Secondary Outcome
Title Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels
Hide Description HCV RNA concentrations were determined using the COBAS TaqMan HCV test (Roche Diagnostics). The linear dynamic range of the assay was 1.2–7.8 log10 IU/mL.
Time Frame 37 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A (MP-424 High) Group B (MP-424 Low)
Hide Arm/Group Description:

Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir

Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks

Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks

Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir

Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks

Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: Log IU / mL
Day 1_2.5h (Group A,B: 10 cases) -0.190  (0.235) -0.220  (0.329)
Day 1_4h (Group A,B: 10 cases) -0.420  (0.264) -0.390  (0.378)
Day 1_8h (Group A,B: 10 cases) -1.300  (0.294) -1.310  (0.309)
Day 1_16h (Group A,B: 10 cases) -2.350  (0.458) -2.480  (0.286)
Day 2 (Group A,B: 10 cases) -3.010  (0.340) -3.180  (0.220)
Day 3 (Group A,B: 10 cases) -3.610  (0.453) -3.790  (0.407)
Day 8 (Group A,B: 10 cases) -4.840  (0.622) -5.010  (0.551)
Day 14 (Group A,B: 10 cases) -5.570  (0.579) -5.800  (0.554)
Day 29 (Group A: 10 cases, Group B: 9 cases) -5.860  (0.611) -5.978  (0.519)
Day 43 (Group A: 8 cases, Group B: 8 cases) -6.000  (0.573) -5.994  (0.590)
Day 57 (Group A: 7 cases, Group B: 8 cases) -5.986  (0.538) -5.994  (0.539)
Day 86 (Group A: 6 cases, Group B: 7 cases) -6.000  (0.588) -6.114  (0.609)
Day 92 (Group A: 6 cases, Group B: 7 cases) -6.000  (0.588) -6.114  (0.609)
Day 99 (Group A: 6 cases, Group B: 7 cases) -6.000  (0.588) -5.471  (1.065)
Day 113 (Group A: 6 cases, Group B: 7 cases) -5.917  (0.564) -3.457  (2.591)
Day 141 (Group A: 6 cases, Group B: 7 cases) -4.233  (2.455) -3.000  (2.865)
Day 169 (Group A: 6 cases, Group B: 6 cases) -3.100  (2.827) -3.267  (3.067)
Day 197 (Group A: 6 cases, Group B: 6 cases) -2.850  (2.947) -3.283  (3.031)
Day 225 (Group A: 6 cases, Group B: 6 cases) -2.633  (2.748) -3.183  (3.140)
Day 253 (Group A: 6 cases, Group B: 6 cases) -1.883  (3.177) -3.100  (3.234)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group A (MP-424 High) Group B (MP-424 Low)
Hide Arm/Group Description

Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir

Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks

Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks

Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir

Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks

Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks

All-Cause Mortality
Group A (MP-424 High) Group B (MP-424 Low)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group A (MP-424 High) Group B (MP-424 Low)
Affected / at Risk (%) Affected / at Risk (%)
Total   2/10 (20.00%)   2/10 (20.00%) 
Blood and lymphatic system disorders     
Anaemia  1/10 (10.00%)  1/10 (10.00%) 
Ear and labyrinth disorders     
Vertigo  1/10 (10.00%)  0/10 (0.00%) 
Metabolism and nutrition disorders     
Appetite disorders  0/10 (0.00%)  1/10 (10.00%) 
Nervous system disorders     
Dizziness  0/10 (0.00%)  1/10 (10.00%) 
Skin and subcutaneous tissue disorders     
Drug eruption  0/10 (0.00%)  1/10 (10.00%) 
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group A (MP-424 High) Group B (MP-424 Low)
Affected / at Risk (%) Affected / at Risk (%)
Total   10/10 (100.00%)   10/10 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  9/10 (90.00%)  8/10 (80.00%) 
Cardiac disorders     
Tachycardia  1/10 (10.00%)  0/10 (0.00%) 
Ear and labyrinth disorders     
Vertigo  0/10 (0.00%)  1/10 (10.00%) 
Deafness  0/10 (0.00%)  1/10 (10.00%) 
Eye disorders     
Abnormal sensation in eye  0/10 (0.00%)  1/10 (10.00%) 
Eye discharge  0/10 (0.00%)  1/10 (10.00%) 
Visual impairment  0/10 (0.00%)  1/10 (10.00%) 
Eye pruritus  1/10 (10.00%)  0/10 (0.00%) 
Gastrointestinal disorders     
Diarrhoea  1/10 (10.00%)  3/10 (30.00%) 
Dyspepsia  2/10 (20.00%)  0/10 (0.00%) 
Abdominal pain upper  0/10 (0.00%)  3/10 (30.00%) 
Constipation  0/10 (0.00%)  1/10 (10.00%) 
Periodontitis  0/10 (0.00%)  1/10 (10.00%) 
Nausea  3/10 (30.00%)  5/10 (50.00%) 
Abdominal discomfort  2/10 (20.00%)  3/10 (30.00%) 
Vomiting  2/10 (20.00%)  3/10 (30.00%) 
Stomatitis  3/10 (30.00%)  1/10 (10.00%) 
Haemorrhoids  1/10 (10.00%)  1/10 (10.00%) 
Proctalgia  1/10 (10.00%)  1/10 (10.00%) 
Abdominal distension  1/10 (10.00%)  0/10 (0.00%) 
Abdominal pain lower  0/10 (0.00%)  1/10 (10.00%) 
Cheilitis  0/10 (0.00%)  1/10 (10.00%) 
Frequent bowel movement  1/10 (10.00%)  0/10 (0.00%) 
Gastritis  1/10 (10.00%)  0/10 (0.00%) 
Reflux oesophagitis  1/10 (10.00%)  0/10 (0.00%) 
General disorders     
Pyrexia  6/10 (60.00%)  8/10 (80.00%) 
Malaise  6/10 (60.00%)  5/10 (50.00%) 
Influenza like illness  4/10 (40.00%)  2/10 (20.00%) 
Injection site erythema  0/10 (0.00%)  1/10 (10.00%) 
Injection site reaction  1/10 (10.00%)  0/10 (0.00%) 
Infections and infestations     
Nasopharyngitis  3/10 (30.00%)  4/10 (40.00%) 
Cystitis  0/10 (0.00%)  1/10 (10.00%) 
Tinea pedis  0/10 (0.00%)  1/10 (10.00%) 
Investigations     
Low density lipoprotein increased  0/10 (0.00%)  3/10 (30.00%) 
Blood uric acid increased  4/10 (40.00%)  4/10 (40.00%) 
Blood triglycerides increased  6/10 (60.00%)  5/10 (50.00%) 
Blood creatinine increased  5/10 (50.00%)  2/10 (20.00%) 
Blood lactate dehydrogenase increased  3/10 (30.00%)  7/10 (70.00%) 
Blood luteinising hormone increased  1/10 (10.00%)  2/10 (20.00%) 
Eosinophil percentage increased  1/10 (10.00%)  1/10 (10.00%) 
Lymphocyte percentage decreased  1/10 (10.00%)  1/10 (10.00%) 
Blood cholesterol increased  0/10 (0.00%)  2/10 (20.00%) 
Platelet count decreased  10/10 (100.00%)  10/10 (100.00%) 
White blood cell count decreased  9/10 (90.00%)  10/10 (100.00%) 
Protein urine present  0/10 (0.00%)  1/10 (10.00%) 
Lymphocyte percentage increased  2/10 (20.00%)  2/10 (20.00%) 
Blood potassium decreased  2/10 (20.00%)  1/10 (10.00%) 
Neutrophil count decreased  2/10 (20.00%)  1/10 (10.00%) 
Basophil percentage decreased  2/10 (20.00%)  1/10 (10.00%) 
Alanine aminotransferase increased  2/10 (20.00%)  0/10 (0.00%) 
Aspartate aminotransferase increased  2/10 (20.00%)  0/10 (0.00%) 
Blood bilirubin unconjugated increased  1/10 (10.00%)  2/10 (20.00%) 
Lipids abnormal  1/10 (10.00%)  2/10 (20.00%) 
Monocyte percentage increased  1/10 (10.00%)  2/10 (20.00%) 
Bilirubin conjugated increased  1/10 (10.00%)  1/10 (10.00%) 
Eosinophil percentage decreased  1/10 (10.00%)  1/10 (10.00%) 
Protein total decreased  0/10 (0.00%)  8/10 (80.00%) 
Blood albumin decreased  0/10 (0.00%)  3/10 (30.00%) 
Blood alkaline phosphatase increased  0/10 (0.00%)  2/10 (20.00%) 
Blood bilirubin increased  0/10 (0.00%)  1/10 (10.00%) 
Blood calcium decreased  0/10 (0.00%)  1/10 (10.00%) 
Blood glucose increased  0/10 (0.00%)  1/10 (10.00%) 
Blood pressure decreased  0/10 (0.00%)  1/10 (10.00%) 
Blood pressure increased  1/10 (10.00%)  0/10 (0.00%) 
Blood thyroid stimulating hormone increased  0/10 (0.00%)  1/10 (10.00%) 
C-reactive protein increased  1/10 (10.00%)  0/10 (0.00%) 
Eosinophil count increased  0/10 (0.00%)  1/10 (10.00%) 
High density lipoprotein decreased  0/10 (0.00%)  1/10 (10.00%) 
Reticulocyte count increased  0/10 (0.00%)  1/10 (10.00%) 
Neutrophil percentage decreased  3/10 (30.00%)  4/10 (40.00%) 
Neutrophil percentage increased  0/10 (0.00%)  1/10 (10.00%) 
Tri-iodothyronine free decreased  0/10 (0.00%)  1/10 (10.00%) 
Metabolism and nutrition disorders     
Hyperuricaemia  5/10 (50.00%)  2/10 (20.00%) 
Decreased appetite  2/10 (20.00%)  1/10 (10.00%) 
Gout  0/10 (0.00%)  1/10 (10.00%) 
Anorexia  3/10 (30.00%)  5/10 (50.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1/10 (10.00%)  1/10 (10.00%) 
Musculoskeletal pain  0/10 (0.00%)  1/10 (10.00%) 
Arthralgia  0/10 (0.00%)  2/10 (20.00%) 
Myalgia  0/10 (0.00%)  1/10 (10.00%) 
Nervous system disorders     
Headache  3/10 (30.00%)  7/10 (70.00%) 
Dysgeusia  3/10 (30.00%)  1/10 (10.00%) 
Dizziness  0/10 (0.00%)  4/10 (40.00%) 
Somnolence  0/10 (0.00%)  1/10 (10.00%) 
Syncope  0/10 (0.00%)  1/10 (10.00%) 
Psychiatric disorders     
Insomnia  1/10 (10.00%)  1/10 (10.00%) 
Affective disorder  1/10 (10.00%)  0/10 (0.00%) 
Anxiety  1/10 (10.00%)  0/10 (0.00%) 
Depression  1/10 (10.00%)  0/10 (0.00%) 
Renal and urinary disorders     
Nocturia  0/10 (0.00%)  1/10 (10.00%) 
Haematuria  0/10 (0.00%)  1/10 (10.00%) 
Pollakiuria  1/10 (10.00%)  0/10 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Choking sensation  0/10 (0.00%)  1/10 (10.00%) 
Cough  0/10 (0.00%)  1/10 (10.00%) 
Nasal congestion  0/10 (0.00%)  1/10 (10.00%) 
Productive cough  0/10 (0.00%)  1/10 (10.00%) 
Rhinorrhoea  1/10 (10.00%)  0/10 (0.00%) 
Oropharyngeal discomfort  1/10 (10.00%)  0/10 (0.00%) 
Oropharyngeal pain  1/10 (10.00%)  0/10 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash  7/10 (70.00%)  7/10 (70.00%) 
Pruritus  3/10 (30.00%)  5/10 (50.00%) 
Alopecia  1/10 (10.00%)  3/10 (30.00%) 
Drug eruption  0/10 (0.00%)  1/10 (10.00%) 
Pain of skin  0/10 (0.00%)  1/10 (10.00%) 
Skin discomfort  0/10 (0.00%)  1/10 (10.00%) 
Skin exfoliation  1/10 (10.00%)  0/10 (0.00%) 
Vascular disorders     
Hypotension  0/10 (0.00%)  1/10 (10.00%) 
1
Term from vocabulary, MedDRA 12.0
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: Clinical Trials, Information Desk
Organization: Mitsubishi Tanabe Pharma Corporation
EMail: cti-inq-ml@ml.mt-pharma.co.jp
Layout table for additonal information
Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00630058     History of Changes
Other Study ID Numbers: G060-A5
First Submitted: February 24, 2008
First Posted: March 6, 2008
Results First Submitted: December 12, 2012
Results First Posted: January 18, 2013
Last Update Posted: May 2, 2014