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Trial record 30 of 50 for:    BI 201335 OR faldaprevir

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 201335 as Softgel Capsule in Naive Hepatitis C Virus (HCV) Patients

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ClinicalTrials.gov Identifier: NCT00947349
Recruitment Status : Completed
First Posted : July 28, 2009
Results First Posted : July 7, 2015
Last Update Posted : July 7, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Conditions Hepatitis C
Pharmacokinetics
Interventions Drug: ribavirin (RBV)
Drug: pegylated interferon (PegIFN) alfa-2a
Drug: BI 201335 NA low placebo
Drug: BI 201335 NA high
Drug: BI 201335 NA low
Drug: BI 201335 NA high placebo
Drug: Placebo
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo in Treatment Naive (TN) Patients BI 201335 NA Low for Treatment Naive (TN) BI 201335 NA High TN BI 201335 NA High for Treatment Experienced (TE)
Hide Arm/Group Description Matching placebo to BI 201335 (Faldaprevir) NA (sodium) with PegIFN/RBV in TN patients Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d. (once daily)) with PegIFN/RBV in treatment naive (TN) patients Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in treatment experienced (TE) patients.
Period Title: Triple Treatment Combination Period
Started 4 6 6 6
Completed 4 5 6 6
Not Completed 0 1 0 0
Reason Not Completed
Adverse Event             0             1             0             0
Period Title: Overall Study Standard of Care
Started 4 5 6 6
Completed 4 5 4 4
Not Completed 0 0 2 2
Reason Not Completed
Lack of Efficacy             0             0             1             1
Withdrawal by Subject             0             0             1             0
not specified             0             0             0             1
Arm/Group Title Placebo in TN Patients BI 201335 NA Low TN BI 201335 NA High TN BI 201335 NA High TE Total
Hide Arm/Group Description Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.). with PegIFN/RBV in TN patients Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients Total of all reporting groups
Overall Number of Baseline Participants 4 6 6 6 22
Hide Baseline Analysis Population Description
The treated set (TS) consisted of all patients who were given study medication and were documented to have taken at least one dose of investigational products regardless of randomisation.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 6 participants 6 participants 6 participants 22 participants
53.5  (6.0) 48.0  (13.5) 56.0  (9.2) 58.0  (8.3) 53.9  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 6 participants 6 participants 6 participants 22 participants
Female
1
  25.0%
4
  66.7%
4
  66.7%
0
   0.0%
9
  40.9%
Male
3
  75.0%
2
  33.3%
2
  33.3%
6
 100.0%
13
  59.1%
1.Primary Outcome
Title Number of Participants With Investigator Defined Drug-related Adverse Events in Triple Combination Therapy
Hide Description Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The treated set (TS) consisted of all patients who were given study medication and were documented to have taken at least one dose of investigational products regardless of randomization randomisation.
Arm/Group Title Triple TN Placebo Triple TN 120 mg Triple TN 240 mg Triple TE 240 mg
Hide Arm/Group Description:
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
Overall Number of Participants Analyzed 4 6 6 6
Measure Type: Number
Unit of Measure: participants
3 6 6 5
2.Primary Outcome
Title Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Triple Combination Therapy
Hide Description Frequency of patients with possible clinically significant abnormalities or clinically significant laboratory test value changes over time in triple combination therapy for treatment naive patients and treatment experienced patients.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The treated set (TS) consisted of all patients who were given study medication and were documented to have taken at least one dose of investigational products regardless of randomisation.
Arm/Group Title Triple TN Placebo Triple TN 120 mg Triple TN 240 mg Triple TE 240 mg
Hide Arm/Group Description:
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
Overall Number of Participants Analyzed 4 6 6 6
Measure Type: Number
Unit of Measure: participants
Decrease Haematocrit 2 2 3 4
Decrease Haemoglobin 3 3 2 4
Decrease Red blood cell ct. 1 2 2 2
Decrease White blood cell ct. 2 4 5 4
Decrease Platelets 0 1 0 0
Increase Eosinophils 0 0 1 0
Decrease Sodium 1 2 2 1
Decrease Potassium 0 0 1 0
Decrease Bicarbonate 0 1 0 1
Increase Bicarbonate 1 2 1 2
Increase Bilirubin, total 0 2 6 5
Increase Bilirubin, direct 0 1 3 4
Increase Protein, total 0 0 1 0
Increase Uric acid 2 2 0 1
Increase Triglyceride 0 0 1 4
Increase U. pH 0 1 0 0
3.Primary Outcome
Title Assessment of Tolerability in Triple Combination Therapy
Hide Description An assessment of tolerability for the safety of the triple combination therapy with BI 201335 NA, PegIFN α -2a and RBV.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The treated set (TS) consisted of all patients who were given study medication and were documented to have taken at least one dose of investigational products regardless of randomisation.
Arm/Group Title Triple TN Placebo Triple TN 120 mg Triple TN 240 mg Triple TE 240 mg
Hide Arm/Group Description:
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
Overall Number of Participants Analyzed 4 6 6 6
Measure Type: Number
Unit of Measure: participants
Good 3 5 5 6
Satisfactory 0 1 1 0
Not Satisfactory 1 0 0 0
Bad 0 0 0 0
4.Secondary Outcome
Title Week 2 Virological Response (W2VR)
Hide Description Number of patients satisfying W2VR (plasma HCV RNA (Hepatitis C Virus Ribonucleic acid) level below the limit of quantification (BLQ))
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.
Arm/Group Title Placebo in TN BI 201335 NA Low TN BI 201335 NA High TN BI 201335 NA High TE
Hide Arm/Group Description:
Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
Overall Number of Participants Analyzed 4 6 6 6
Measure Type: Number
Unit of Measure: participants
0 5 6 3
5.Secondary Outcome
Title Week 4 Virological Response (W4VR)
Hide Description Number of patients satisfying W4VR (plasma HCV RNA level below the limit of quantification (BLQ))
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.
Arm/Group Title Placebo TN BI 201335 NA Low TN BI 201335 NA High TN BI 201335 NA High TE
Hide Arm/Group Description:
Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
Overall Number of Participants Analyzed 4 6 6 6
Measure Type: Number
Unit of Measure: participants
0 6 6 5
6.Secondary Outcome
Title Rapid Virological Response (RVR)
Hide Description Number of patients satisfying RVR (plasma HCV RNA level below the limit of detection (BLD) at Week 4)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.
Arm/Group Title Placebo TN BI 201335 NA Low TN BI 201335 NA High TN BI 201335 NA High TE
Hide Arm/Group Description:
Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
Overall Number of Participants Analyzed 4 6 6 6
Measure Type: Number
Unit of Measure: participants
0 5 6 4
7.Secondary Outcome
Title Change From Baseline in HCV Viral Load
Hide Description Change form baseline in HCV viral load (log10) after 4 weeks
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.
Arm/Group Title Placebo TN BI 201335 NA Low TN BI 201335 NA High TN BI 201335 NA High TE
Hide Arm/Group Description:
Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
Overall Number of Participants Analyzed 4 6 6 6
Mean (Standard Error)
Unit of Measure: IU/mL
-3.30  (0.74) -5.88  (0.17) -5.95  (0.21) -5.53  (0.29)
8.Secondary Outcome
Title Day 28 Virologic Response
Hide Description Number of patients with HCV viral load reduction >= 2 log10 at Week 4
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.
Arm/Group Title Placebo TN BI 201335 NA Low TN BI 201335 NA High TN BI 201335 NA High TE
Hide Arm/Group Description:
Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
Overall Number of Participants Analyzed 4 6 6 6
Measure Type: Number
Unit of Measure: participants
3 6 6 6
9.Secondary Outcome
Title Early Virological Response (EVR)
Hide Description Number of patients with reduction >= 2 log10 in plasma HCV RNA level at Week 12
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.
Arm/Group Title Placebo TN BI 201335 NA Low TN BI 201335 NA High TN BI 201335 NA High TE
Hide Arm/Group Description:
Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
Overall Number of Participants Analyzed 4 6 6 6
Measure Type: Number
Unit of Measure: participants
4 5 6 6
10.Secondary Outcome
Title Complete Early Virological Response (cEVR)
Hide Description Number of patients with plasma HCV RNA level BLD at Week 12
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.
Arm/Group Title Placebo TN BI 201335 NA Low TN BI 201335 NA High TN BI 201335 NA High TE
Hide Arm/Group Description:
Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
Overall Number of Participants Analyzed 4 6 6 6
Measure Type: Number
Unit of Measure: participants
3 5 5 6
11.Secondary Outcome
Title End of Treatment Response (ETR)
Hide Description Number of patients with plasma HCV RNA level BLD at week 48
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.
Arm/Group Title Placebo TN BI 201335 NA Low TN BI 201335 NA High TN BI 201335 NA High TE
Hide Arm/Group Description:
Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
Overall Number of Participants Analyzed 4 6 6 6
Measure Type: Number
Unit of Measure: participants
3 5 4 4
12.Secondary Outcome
Title Sustained Virologic Response (SVR)
Hide Description Number of patients with plasma HCV RNA level BLD 24 weeks after treatment completion
Time Frame 72 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.
Arm/Group Title Placebo TN BI 201335 NA Low TN BI 201335 NA High TN BI 201335 NA High TE
Hide Arm/Group Description:
Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
Overall Number of Participants Analyzed 4 6 6 6
Measure Type: Number
Unit of Measure: participants
2 4 5 3
13.Secondary Outcome
Title Number of Participants With Investigator Defined Drug-related Adverse Events in Standard of Care (SOC) With PegIFN α-2a and RBV
Hide Description Drug-related AEs in SOC treatment period were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.
Time Frame 44 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The treated set (TS) consisted of all patients who were given study medication and were documented to have taken at least one dose of investigational products regardless of randomisation.
Arm/Group Title SOC TN Placebo SOC TN 120 mg SOC TN 240 mg SOC TE 240 mg
Hide Arm/Group Description:
Standard of care (SOC) for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
Standard of care for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
Standard of care for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
Standard of care for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
Overall Number of Participants Analyzed 4 5 6 6
Measure Type: Number
Unit of Measure: participant(s)
3 5 4 5
14.Secondary Outcome
Title Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Standard of Care (SOC) With PegIFN α-2a and RBV
Hide Description Frequency of patients with possible clinically significant abnormalities or clinically significant laboratory test value changes over time in SOC period for treatment naive patients and treatment experienced patients.
Time Frame 44 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title SOC TN Placebo SOC TN 120 mg SOC TN 240 mg SOC TE 240 mg
Hide Arm/Group Description:
Standard of care (SOC) for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
Standard of care for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
Standard of care for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
Standard of care for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
Overall Number of Participants Analyzed 4 5 6 6
Measure Type: Number
Unit of Measure: participant(s)
Decrease haematocrit 1 3 5 4
Decrease haemoglobin 4 2 2 5
Decrease red blood cell ct. 0 3 4 3
Decrease white blood cell ct. 3 5 5 3
Decrease platelets 0 1 0 0
Increase eosinophils 0 0 1 1
Decrease sodium 1 0 1 0
Decrease potassium 0 0 1 0
Increase bicarbonate 0 1 0 0
Increase uric acid 1 0 0 0
Increase triglyceride 1 0 0 2
Increase U. pH 0 2 0 0
Increase AST/GOT, SGOT 0 1 0 1
Increase ALT/GPT, SGPT 0 1 0 1
15.Secondary Outcome
Title Assessment of Tolerability in Standard of Care (SOC) With PegIFN α -2a and RBV
Hide Description An assessment of tolerability for the safety of the SOC with PegIFN alfa-2a and RBV.
Time Frame 44 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title SOC TN Placebo SOC TN 120 mg SOC TN 240 mg SOC TE 240 mg
Hide Arm/Group Description:
Standard of care (SOC) for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
Standard of care for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
Standard of care for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
Standard of care for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
Overall Number of Participants Analyzed 4 5 6 6
Measure Type: Number
Unit of Measure: participant(s)
Good 2 4 1 3
Satisfactory 2 0 2 1
Not satisfactory 0 1 1 2
Bad 0 0 2 0
16.Secondary Outcome
Title AUCτ,1 for BI 201335 ZW
Hide Description Area under the curve (AUC) concentration after the first dose of BI 201335 ZW
Time Frame 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.
Arm/Group Title BI 201335 NA Low TN BI 201335 NA High TN BI 201335 NA High TE
Hide Arm/Group Description:
Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
Overall Number of Participants Analyzed 6 4 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
68900
(25.3%)
171000
(21.2%)
233000
(38.5%)
17.Secondary Outcome
Title Cmax of BI 201335 ZW
Hide Description Maximum concentration of BI 201335 ZW after multiple oral admin. of BI 201335 NA with RBV and PegIFN alfa-2a
Time Frame 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.
Arm/Group Title BI 201335 NA Low TN BI 201335 NA High TN BI 201335 NA High TE
Hide Arm/Group Description:
Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
Overall Number of Participants Analyzed 6 4 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
5500
(24.4%)
12600
(29.0%)
15000
(40.0%)
18.Secondary Outcome
Title AUCτ,ss of BI 201335 ZW
Hide Description AUC at steady state after 4 weeks combination of the last dose
Time Frame 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.
Arm/Group Title BI 201335 NA Low TN BI 201335 NA High TN BI 201335 NA High TE
Hide Arm/Group Description:
Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
Overall Number of Participants Analyzed 5 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
70800
(86.5%)
361000
(68.0%)
499000
(41.3%)
19.Secondary Outcome
Title Cmax,ss of BI 201335 ZW
Hide Description Maximum concentration of BI 201335 ZW at steady state
Time Frame 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.
Arm/Group Title BI 201335 NA Low TN BI 201335 NA High TN BI 201335 NA High TE
Hide Arm/Group Description:
Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
Overall Number of Participants Analyzed 5 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
5880
(61.5%)
24500
(52.2%)
29100
(35.3%)
20.Secondary Outcome
Title AUCτ,1 for Ribavirin (RBV)
Hide Description Area under the plasma concentration curve of RBV after the first dose of placebo or BI 201335 NA with with RBV and PegIFN alfa-2a
Time Frame -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the first dose
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.
Arm/Group Title Placebo TN BI 201335 NA Low TN BI 201335 NA High TN BI 201335 NA High TE
Hide Arm/Group Description:
Matching placebo to BI 201335 NA with RBV and PegIFN alfa-2a in TN patients
Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
Overall Number of Participants Analyzed 4 6 4 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
5160
(22.1%)
4660
(35.8%)
4620
(22.9%)
3500
(41.2%)
21.Secondary Outcome
Title Cmax of RBV
Hide Description Maximum Plasma concentration of RBV after multiple oral admin. of placebo with RBV and PegIFN alfa-2a
Time Frame -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the first dose
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.
Arm/Group Title Placebo TN BI 201335 NA Low TN BI 201335 NA High TN BI 201335 NA High TE
Hide Arm/Group Description:
Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
Overall Number of Participants Analyzed 4 6 4 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
1130
(24.9%)
761
(29.7%)
724
(33.7%)
509
(51.0%)
22.Secondary Outcome
Title AUCτ,ss of RBV
Hide Description Area under the plasma concentration curve of RBV after the multiple oral administration of BI 201335 NA (or placebo) with RBV and PegIFN alfa-2a at steady state
Time Frame -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the last dose
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.
Arm/Group Title Placebo TN BI 201335 NA Low TN BI 201335 NA High TN BI 201335 NA High TE
Hide Arm/Group Description:
Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
Overall Number of Participants Analyzed 4 6 5 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
27500
(29.5%)
25200
(42.4%)
22400
(38.5%)
20000
(18.7%)
23.Secondary Outcome
Title Cmax,ss of RBV
Hide Description Maximum Plasma concentration of RBV after multiple oral admin. of BI 201335 NA (or placebo) with RBV and PegIFN alfa-2a at steady state
Time Frame -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the last dose
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.
Arm/Group Title Placebo TN BI 201335 NA Low TN BI 201335 NA High TN BI 201335 NA High TE
Hide Arm/Group Description:
Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
Overall Number of Participants Analyzed 4 5 5 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
3060
(35.4%)
2710
(47.3%)
2280
(43.2%)
2130
(18.0%)
24.Secondary Outcome
Title Tmax for BI 201335 ZW
Hide Description Time to maximum plasma concentration (tmax) of BI 201335 ZW after the first dose of BI 201335 NA with RBV and PegIFN alfa-2a
Time Frame 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title BI 201335 NA Low TN BI 201335 NA High TN BI 201335 NA High TE
Hide Arm/Group Description:
Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
Overall Number of Participants Analyzed 6 4 6
Median (Full Range)
Unit of Measure: hour(s)
4.98
(3.92 to 9.88)
5.50
(4.03 to 7.93)
7.97
(2.88 to 9.92)
25.Secondary Outcome
Title Tmax for RBV
Hide Description Time to maximum plasma concentration (tmax) of RBV after the first dose of BI 201335 NA with RBV and PegIFN alfa-2a
Time Frame 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title Placebo TN BI 201335 NA Low TN BI 201335 NA High TN BI 201335 NA High TE
Hide Arm/Group Description:
Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
Overall Number of Participants Analyzed 4 6 4 6
Median (Full Range)
Unit of Measure: hour(s)
1.94
(0.917 to 3.00)
3.98
(2.00 to 4.88)
3.92
(2.05 to 5.97)
4.98
(1.97 to 6.02)
26.Secondary Outcome
Title Tmax, ss for BI 201335 ZW
Hide Description Time from last dosing to the maximum plasma concentration (tmax) of BI 201335 ZW after the last dose of BI 201335 NA with RBV and PegIFN alfa-2a at steady state
Time Frame 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title BI 201335 NA Low TN BI 201335 NA High TN BI 201335 NA High TE
Hide Arm/Group Description:
Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
Overall Number of Participants Analyzed 5 6 6
Median (Full Range)
Unit of Measure: hour(s)
3.83
(1.85 to 5.07)
2.99
(2.90 to 3.05)
3.49
(2.92 to 4.03)
27.Secondary Outcome
Title Tmax, ss for RBV
Hide Description Time to the maximum plasma concentration (tmax) of RBV after the last dose of BI 201335 NA with RBV and PegIFN alfa-2a at steady state
Time Frame 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title Placebo TN BI 201335 NA Low TN BI 201335 NA High TN BI 201335 NA High TE
Hide Arm/Group Description:
Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
Overall Number of Participants Analyzed 4 5 5 6
Median (Full Range)
Unit of Measure: hour(s)
2.42
(0.90 to 3.93)
2.92
(1.85 to 4.08)
2.90
(1.93 to 5.88)
3.92
(2.00 to 5.03)
28.Secondary Outcome
Title t1/2,ss for BI 201335 ZW
Hide Description terminal half-life of the analyte in plasma at steady state (t1/2,ss)
Time Frame 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title BI 201335 NA Low TN BI 201335 NA High TN BI 201335 NA High TE
Hide Arm/Group Description:
Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
Overall Number of Participants Analyzed 5 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hour(s)
29.3
(7.70%)
21.2
(9.00%)
23.0
(19.8%)
29.Secondary Outcome
Title Cmin,ss for BI 201335 ZW
Hide Description Minimum concentration of the analyte (BI 201335 ZW) in plasma over the dosing interval at steady state
Time Frame 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title BI 201335 NA Low TN BI 201335 NA High TN BI 201335 NA High TE
Hide Arm/Group Description:
Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
Overall Number of Participants Analyzed 5 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
1550
(138%)
10200
(85.0%)
16000
(54.1%)
30.Secondary Outcome
Title Cmin,ss for RBV
Hide Description Minimum concentration of the analyte (RBV) in plasma over the dosing interval at steady state
Time Frame 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title Placebo TN BI 201335 NA Low TN BI 201335 NA High TN BI 201335 NA High TE
Hide Arm/Group Description:
Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
Overall Number of Participants Analyzed 4 5 5 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
1980
(24.6%)
1730
(44.0%)
1590
(36.4%)
1400
(18.5%)
31.Secondary Outcome
Title Cavg for BI 201335 ZW
Hide Description average plasma concentration (Cavg) of BI 201335 ZW
Time Frame 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title BI 201335 NA Low TN BI 201335 NA High TN BI 201335 NA High TE
Hide Arm/Group Description:
Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
Overall Number of Participants Analyzed 5 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
2950
(86.5%)
15000
(68.0%)
20800
(41.3%)
32.Secondary Outcome
Title Cavg for RBV
Hide Description average plasma concentration (Cavg) of RBV
Time Frame 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title Placebo TN BI 201335 NA Low TN BI 201335 NA High TN BI 201335 NA High TE
Hide Arm/Group Description:
Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
Overall Number of Participants Analyzed 4 5 5 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
2290
(29.5%)
2100
(42.4%)
1860
(38.5%)
1670
(18.7%)
33.Secondary Outcome
Title CL/F,ss for BI 201335 ZW
Hide Description apparent clearance of the analyte (BI 201335 ZW) in plasma at steady state (CL/F,ss) following multiple oral administration
Time Frame 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title BI 201335 NA Low TN BI 201335 NA High TN BI 201335 NA High TE
Hide Arm/Group Description:
Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
Overall Number of Participants Analyzed 5 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/min
28.2
(86.5%)
11.1
(68.0%)
8.01
(41.3%)
Time Frame up to 72 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Triple TN Placebo Triple TN 120 mg Triple TN 240 mg Triple TE 240 mg SOC TN Placebo SOC TN 120 mg SOC TN 240 mg SOC TE 240 mg
Hide Arm/Group Description Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with IFN/RBV) Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with IFN/RBV. Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with IFN/RBV. Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with IFN/RBV. Standard of care for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with IFN/RBV) Standard of care for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with IFN/RBV. Standard of care for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with IFN/RBV. Standard of care for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with IFN/RBV.
All-Cause Mortality
Triple TN Placebo Triple TN 120 mg Triple TN 240 mg Triple TE 240 mg SOC TN Placebo SOC TN 120 mg SOC TN 240 mg SOC TE 240 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Triple TN Placebo Triple TN 120 mg Triple TN 240 mg Triple TE 240 mg SOC TN Placebo SOC TN 120 mg SOC TN 240 mg SOC TE 240 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   1/6 (16.67%)   0/6 (0.00%)   0/6 (0.00%)   1/4 (25.00%)   0/5 (0.00%)   0/6 (0.00%)   0/6 (0.00%) 
Gastrointestinal disorders                 
Abdominal pain  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Abdominal pain upper  1  0/4 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Triple TN Placebo Triple TN 120 mg Triple TN 240 mg Triple TE 240 mg SOC TN Placebo SOC TN 120 mg SOC TN 240 mg SOC TE 240 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/4 (75.00%)   6/6 (100.00%)   6/6 (100.00%)   6/6 (100.00%)   3/4 (75.00%)   5/5 (100.00%)   5/6 (83.33%)   5/6 (83.33%) 
Blood and lymphatic system disorders                 
Iron deficiency anaemia  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Neutropenia  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Endocrine disorders                 
Basedow's disease  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Eye disorders                 
Ocular icterus  1  0/4 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Pingueculitis  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Retinopathy  1  0/4 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Vitreous floaters  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Gastrointestinal disorders                 
Abdominal discomfort  1  0/4 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  2/6 (33.33%)  0/4 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Abdominal pain upper  1  1/4 (25.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Cheilitis  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Colitis  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Constipation  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  1/5 (20.00%)  0/6 (0.00%)  0/6 (0.00%) 
Dental caries  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/6 (0.00%)  0/6 (0.00%) 
Diarrhoea  1  0/4 (0.00%)  1/6 (16.67%)  2/6 (33.33%)  0/6 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Dyspepsia  1  1/4 (25.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Gastritis atrophic  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Haemorrhoids  1  0/4 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Lip erosion  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Nausea  1  1/4 (25.00%)  2/6 (33.33%)  1/6 (16.67%)  0/6 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Periodontitis  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/6 (0.00%)  0/6 (0.00%) 
Periproctitis  1  0/4 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Vomiting  1  1/4 (25.00%)  0/6 (0.00%)  3/6 (50.00%)  0/6 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
General disorders                 
Fatigue  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Feeling hot  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Influenza like illness  1  1/4 (25.00%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Malaise  1  1/4 (25.00%)  1/6 (16.67%)  2/6 (33.33%)  2/6 (33.33%)  0/4 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Oedema  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Pain  1  0/4 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Pyrexia  1  0/4 (0.00%)  2/6 (33.33%)  2/6 (33.33%)  2/6 (33.33%)  1/4 (25.00%)  1/5 (20.00%)  0/6 (0.00%)  1/6 (16.67%) 
Hepatobiliary disorders                 
Jaundice  1  0/4 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Infections and infestations                 
Bronchitis  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Cellulitis  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Nasopharyngitis  1  0/4 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  4/5 (80.00%)  1/6 (16.67%)  1/6 (16.67%) 
Oral herpes  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/6 (0.00%)  0/6 (0.00%) 
Upper respiratory tract infection  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  1/5 (20.00%)  0/6 (0.00%)  0/6 (0.00%) 
Vaginitis bacterial  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/6 (0.00%)  0/6 (0.00%) 
Injury, poisoning and procedural complications                 
Fall  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Investigations                 
Alanine aminotransferase increased  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Bilirubin conjugated increased  1  0/4 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Blood bilirubin increased  1  0/4 (0.00%)  1/6 (16.67%)  2/6 (33.33%)  2/6 (33.33%)  0/4 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Haemoglobin decreased  1  1/4 (25.00%)  1/6 (16.67%)  2/6 (33.33%)  1/6 (16.67%)  0/4 (0.00%)  3/5 (60.00%)  2/6 (33.33%)  1/6 (16.67%) 
Liver function test abnormal  1  1/4 (25.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Neutrophil count decreased  1  1/4 (25.00%)  1/6 (16.67%)  4/6 (66.67%)  1/6 (16.67%)  1/4 (25.00%)  1/5 (20.00%)  0/6 (0.00%)  0/6 (0.00%) 
Weight decreased  1  1/4 (25.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Metabolism and nutrition disorders                 
Decreased appetite  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  1/6 (16.67%)  1/6 (16.67%) 
Musculoskeletal and connective tissue disorders                 
Arthralgia  1  0/4 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Back pain  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Nervous system disorders                 
Dizziness  1  0/4 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  1/6 (16.67%)  0/6 (0.00%) 
Dysgeusia  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/6 (0.00%)  0/6 (0.00%) 
Headache  1  1/4 (25.00%)  2/6 (33.33%)  1/6 (16.67%)  1/6 (16.67%)  0/4 (0.00%)  2/5 (40.00%)  0/6 (0.00%)  1/6 (16.67%) 
Hypoaesthesia  1  0/4 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Loss of consciousness  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Somnolence  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Psychiatric disorders                 
Depression  1  0/4 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Insomnia  1  1/4 (25.00%)  2/6 (33.33%)  0/6 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/5 (0.00%)  1/6 (16.67%)  1/6 (16.67%) 
Reproductive system and breast disorders                 
Dysmenorrhoea  1  0/4 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Cough  1  0/4 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Dyspnoea  1  1/4 (25.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Hyperventilation  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Oropharyngeal pain  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/6 (0.00%)  1/6 (16.67%) 
Upper respiratory tract inflammation  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/6 (0.00%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders                 
Alopecia  1  0/4 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Dry skin  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/4 (50.00%)  1/5 (20.00%)  0/6 (0.00%)  0/6 (0.00%) 
Eczema  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/6 (0.00%)  0/6 (0.00%) 
Eczema asteatotic  1  0/4 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Pruritus  1  1/4 (25.00%)  1/6 (16.67%)  2/6 (33.33%)  1/6 (16.67%)  2/4 (50.00%)  1/5 (20.00%)  1/6 (16.67%)  0/6 (0.00%) 
Rash  1  1/4 (25.00%)  3/6 (50.00%)  2/6 (33.33%)  1/6 (16.67%)  0/4 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Rash generalised  1  0/4 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Vascular disorders                 
Lymphocele  1  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 14.0
Additional secondary endpoints were listed in the original protocol. Those endpoints are of exploratory nature only and were not considered relevant for trial conclusions. For more information see tab “Full Text Review”, section “More Information".
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.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI’s intellectual property rights.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00947349     History of Changes
Other Study ID Numbers: 1220.14
First Submitted: July 21, 2009
First Posted: July 28, 2009
Results First Submitted: January 22, 2015
Results First Posted: July 7, 2015
Last Update Posted: July 7, 2015