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Trial record 11 of 50 for:    BI 201335 OR faldaprevir

Pharmacokinetics of Faldaprevir of Soft Capsule

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ClinicalTrials.gov Identifier: NCT01821937
Recruitment Status : Completed
First Posted : April 1, 2013
Results First Posted : August 3, 2015
Last Update Posted : August 3, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy
Interventions Drug: faldaprevir(high dose)
Drug: Faldaprevir(low dose)
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Faldaprevir 120 mg Faldaprevir 240 mg
Hide Arm/Group Description

Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.

The study was divided into two phases, the first being a single dose and the second a multiple dose.

During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.

During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.

Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.

The study was divided into two phases, the first being a single dose and the second a multiple dose.

During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.

During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.

Period Title: Overall Study
Started 10 15
Completed 10 12 [1]
Not Completed 0 3
Reason Not Completed
Adverse Event             0             3
[1]
2 patients discontinued during Single dose period,1 Patient discontinued during Multiple dose period
Arm/Group Title Faldaprevir 120 mg Faldaprevir 240 mg Total
Hide Arm/Group Description

Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.

The study was divided into two phases, the first being a single dose and the second a multiple dose.

During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.

During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.

Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule

The study was divided into two phases, the first being a single dose and the second a multiple dose.

During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.

During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.

Total of all reporting groups
Overall Number of Baseline Participants 10 15 25
Hide Baseline Analysis Population Description
Treated Set (TS): This set included all 25 subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 15 participants 25 participants
25.3  (4.5) 24.8  (5.7) 25.0  (5.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 15 participants 25 participants
Female
5
  50.0%
8
  53.3%
13
  52.0%
Male
5
  50.0%
7
  46.7%
12
  48.0%
1.Primary Outcome
Title Cmax,ss (After Multiple Dosing)
Hide Description C(max,ss) is defined as maximum measured concentration of Faldaprevir in plasma at steady state over a uniform dosing interval tau.
Time Frame Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228, 240 h after first administration of Faldaprevir
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set (PKS): This set included all subjects in TS who provided at least one Pharmacokinetic (PK) endpoint and had no important protocol violations relevant to the evaluation of PK and provided no emesis with onset at or before twice the median t max .
Arm/Group Title Faldaprevir 120 mg Faldaprevir 240 mg
Hide Arm/Group Description:

Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.

The study was divided into two phases, the first being a single dose and the second a multiple dose.

During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.

During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.

Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.

The study was divided into two phases, the first being a single dose and the second a multiple dose.

During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.

During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.

Overall Number of Participants Analyzed 10 11
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
3270
(44.0%)
14200
(35.5%)
2.Primary Outcome
Title AUC(Tau,ss) (After Multiple Dosing)
Hide Description AUC(tau,ss) is defined as area under the concentration-time curve of Faldaprevir in plasma at steady state over a uniform dosing interval tau.
Time Frame Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228,240 h after first administration of Faldaprevir
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set (PKS): This set included all subjects in TS who provided at least one PK endpoint and had no important protocol violations relevant to the evaluation of PK and provided no emesis with onset at or before twice the median t max .
Arm/Group Title Faldaprevir 120 mg Faldaprevir 240 mg
Hide Arm/Group Description:

Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.

The study was divided into two phases, the first being a single dose and the second a multiple dose.

During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.

During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.

Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.

The study was divided into two phases, the first being a single dose and the second a multiple dose.

During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.

During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.

Overall Number of Participants Analyzed 10 11
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
36200
(48.5%)
199000
(49.5%)
3.Secondary Outcome
Title Cmax (After Single Dosing)
Hide Description Cmax is defined as maximum measured concentration of Faldaprevir in plasma.
Time Frame Before drug administration and 0.5 hours(h), 1,1.5,2,3,4,6,8,12,24,48,72,96h after administration of Faldaprevir
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set (PKS): This set included all subjects in TS who provided at least one PK endpoint and had no important protocol violations relevant to the evaluation of PK and provided no emesis with onset at or before twice the median t max .
Arm/Group Title Faldaprevir 120 mg Faldaprevir 240 mg
Hide Arm/Group Description:

Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.

The study was divided into two phases, the first being a single dose and the second a multiple dose.

During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.

During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.

Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.

The study was divided into two phases, the first being a single dose and the second a multiple dose.

During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.

During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.

Overall Number of Participants Analyzed 10 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
664
(48.7%)
2060
(44.3%)
4.Secondary Outcome
Title AUC(0-tz) (After Single Dosing)
Hide Description AUC (0-tz) is defined as area under the concentration-time curve of the analyte in plasma over the respective time interval, where t and z define beginning and end times of the time interval.
Time Frame Before drug administration and 0.5 hours(h), 1,1.5,2,3,4,6,8,12,24,48,72,96h after administration of Faldaprevir
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set (PKS): This set included all subjects in TS who provided at least one PK endpoint and had no important protocol violations relevant to the evaluation of PK and provided no emesis with onset at or before twice the median t max .
Arm/Group Title Faldaprevir 120 mg Faldaprevir 240 mg
Hide Arm/Group Description:

Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.

The study was divided into two phases, the first being a single dose and the second a multiple dose.

During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.

During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.

Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.

The study was divided into two phases, the first being a single dose and the second a multiple dose.

During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.

During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.

Overall Number of Participants Analyzed 10 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
14600
(38.9%)
37900
(45.5%)
5.Secondary Outcome
Title t(1/2,ss) (After Multiple Dosing)
Hide Description t(1/2,ss) is defined as the terminal half-life of Faldaprevir in plasma at steady state.
Time Frame Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228,240 h after first administration of Faldaprevir
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set (PKS): This set included all subjects in TS who provided at least one PK endpoint and had no important protocol violations relevant to the evaluation of PK and provided no emesis with onset at or before twice the median t max .
Arm/Group Title Faldaprevir 120 mg Faldaprevir 240 mg
Hide Arm/Group Description:

Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.

The study was divided into two phases, the first being a single dose and the second a multiple dose.

During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.

During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.

Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.

The study was divided into two phases, the first being a single dose and the second a multiple dose.

During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.

During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.

Overall Number of Participants Analyzed 10 11
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hour
31.2
(9.27%)
20.0
(23.6%)
6.Secondary Outcome
Title Tmax,ss (After Multiple Dosing)
Hide Description tmax,ss is defined as the time from last dosing to the maximum measured concentration of Faldaprevir in plasma at steady state
Time Frame Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228, 240 h after first administration of Faldaprevir
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set (PKS): This set included all subjects in TS who provided at least one PK endpoint and had no important protocol violations relevant to the evaluation of PK and provided no emesis with onset at or before twice the median t max .
Arm/Group Title Faldaprevir 120 mg Faldaprevir 240 mg
Hide Arm/Group Description:

Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.

The study was divided into two phases, the first being a single dose and the second a multiple dose.

During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.

During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.

Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.

The study was divided into two phases, the first being a single dose and the second a multiple dose.

During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.

During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.

Overall Number of Participants Analyzed 10 11
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hour
2.85
(33.6%)
2.44
(29.8%)
Time Frame From first intake of the trial medication until the end of the trial (Up to Day 16)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Faldaprevir 120 mg Single Dose Faldaprevir 120 mg Multiple Dose Faldaprevir 240 mg Single Dose Faldaprevir 240 mg Multiple Dose
Hide Arm/Group Description

Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.

The study was divided into two phases, the first being a single dose and the second a multiple dose.

During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.

Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.

The study was divided into two phases, the first being a single dose and the second a multiple dose.

During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.

Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule

The study was divided into two phases, the first being a single dose and the second a multiple dose.

During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.

Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule

The study was divided into two phases, the first being a single dose and the second a multiple dose.

During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15.

All-Cause Mortality
Faldaprevir 120 mg Single Dose Faldaprevir 120 mg Multiple Dose Faldaprevir 240 mg Single Dose Faldaprevir 240 mg Multiple Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Faldaprevir 120 mg Single Dose Faldaprevir 120 mg Multiple Dose Faldaprevir 240 mg Single Dose Faldaprevir 240 mg Multiple Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%)   0/15 (0.00%)   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Faldaprevir 120 mg Single Dose Faldaprevir 120 mg Multiple Dose Faldaprevir 240 mg Single Dose Faldaprevir 240 mg Multiple Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/10 (70.00%)   10/10 (100.00%)   13/15 (86.67%)   13/13 (100.00%) 
Gastrointestinal disorders         
Abdominal discomfort  1  1/10 (10.00%)  1/10 (10.00%)  0/15 (0.00%)  1/13 (7.69%) 
Abdominal pain  1  1/10 (10.00%)  0/10 (0.00%)  0/15 (0.00%)  2/13 (15.38%) 
Abdominal pain lower  1  0/10 (0.00%)  1/10 (10.00%)  0/15 (0.00%)  0/13 (0.00%) 
Abdominal pain upper  1  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  2/13 (15.38%) 
Diarrhoea  1  0/10 (0.00%)  2/10 (20.00%)  0/15 (0.00%)  4/13 (30.77%) 
Dyspepsia  1  2/10 (20.00%)  2/10 (20.00%)  5/15 (33.33%)  8/13 (61.54%) 
Epigastric discomfort  1  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  1/13 (7.69%) 
Faeces discoloured  1  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  1/13 (7.69%) 
Nausea  1  2/10 (20.00%)  2/10 (20.00%)  3/15 (20.00%)  3/13 (23.08%) 
Vomiting  1  0/10 (0.00%)  0/10 (0.00%)  2/15 (13.33%)  2/13 (15.38%) 
General disorders         
Pyrexia  1  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  3/13 (23.08%) 
Investigations         
Alanine aminotransferase abnormal  1  0/10 (0.00%)  1/10 (10.00%)  0/15 (0.00%)  0/13 (0.00%) 
Alanine aminotransferase increased  1  0/10 (0.00%)  0/10 (0.00%)  1/15 (6.67%)  0/13 (0.00%) 
Aspartate aminotransferase increased  1  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  1/13 (7.69%) 
Bile output abnormal  1  0/10 (0.00%)  1/10 (10.00%)  0/15 (0.00%)  1/13 (7.69%) 
Bile output increased  1  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  1/13 (7.69%) 
Bilirubin conjugated abnormal  1  0/10 (0.00%)  5/10 (50.00%)  0/15 (0.00%)  6/13 (46.15%) 
Bilirubin conjugated increased  1  0/10 (0.00%)  3/10 (30.00%)  1/15 (6.67%)  8/13 (61.54%) 
Blood bilirubin abnormal  1  0/10 (0.00%)  6/10 (60.00%)  0/15 (0.00%)  7/13 (53.85%) 
Blood bilirubin increased  1  0/10 (0.00%)  3/10 (30.00%)  1/15 (6.67%)  7/13 (53.85%) 
Blood bilirubin unconjugated increased  1  0/10 (0.00%)  8/10 (80.00%)  1/15 (6.67%)  12/13 (92.31%) 
Blood cholesterol abnormal  1  0/10 (0.00%)  1/10 (10.00%)  0/15 (0.00%)  0/13 (0.00%) 
Blood cholesterol increased  1  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  1/13 (7.69%) 
Blood creatine phosphokinase abnormal  1  1/10 (10.00%)  0/10 (0.00%)  0/15 (0.00%)  0/13 (0.00%) 
Blood glucose increased  1  0/10 (0.00%)  0/10 (0.00%)  1/15 (6.67%)  0/13 (0.00%) 
Blood lactate dehydrogenase abnormal  1  1/10 (10.00%)  1/10 (10.00%)  0/15 (0.00%)  0/13 (0.00%) 
Blood lactate dehydrogenase increased  1  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  2/13 (15.38%) 
Blood potassium abnormal  1  0/10 (0.00%)  1/10 (10.00%)  0/15 (0.00%)  0/13 (0.00%) 
Blood triglycerides abnormal  1  0/10 (0.00%)  0/10 (0.00%)  2/15 (13.33%)  0/13 (0.00%) 
Blood triglycerides increased  1  1/10 (10.00%)  0/10 (0.00%)  1/15 (6.67%)  1/13 (7.69%) 
Haemoglobin decreased  1  1/10 (10.00%)  0/10 (0.00%)  0/15 (0.00%)  0/13 (0.00%) 
Haptoglobin abnormal  1  1/10 (10.00%)  0/10 (0.00%)  0/15 (0.00%)  0/13 (0.00%) 
Haptoglobin decreased  1  0/10 (0.00%)  0/10 (0.00%)  1/15 (6.67%)  1/13 (7.69%) 
Lipase abnormal  1  1/10 (10.00%)  0/10 (0.00%)  1/15 (6.67%)  0/13 (0.00%) 
Lipase increased  1  2/10 (20.00%)  1/10 (10.00%)  0/15 (0.00%)  1/13 (7.69%) 
Protein total abnormal  1  0/10 (0.00%)  0/10 (0.00%)  1/15 (6.67%)  0/13 (0.00%) 
Protein urine present  1  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  1/13 (7.69%) 
Total bile acids increased  1  1/10 (10.00%)  1/10 (10.00%)  1/15 (6.67%)  2/13 (15.38%) 
Urine bilirubin increased  1  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  3/13 (23.08%) 
Urobilinogen urine increased  1  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  3/13 (23.08%) 
White blood cell count decreased  1  0/10 (0.00%)  1/10 (10.00%)  0/15 (0.00%)  0/13 (0.00%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  0/10 (0.00%)  1/10 (10.00%)  0/15 (0.00%)  0/13 (0.00%) 
Myalgia  1  0/10 (0.00%)  2/10 (20.00%)  1/15 (6.67%)  1/13 (7.69%) 
Pain in extremity  1  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  1/13 (7.69%) 
Nervous system disorders         
Dizziness  1  1/10 (10.00%)  1/10 (10.00%)  0/15 (0.00%)  2/13 (15.38%) 
Somnolence  1  1/10 (10.00%)  3/10 (30.00%)  0/15 (0.00%)  2/13 (15.38%) 
Renal and urinary disorders         
Chromaturia  1  0/10 (0.00%)  2/10 (20.00%)  1/15 (6.67%)  4/13 (30.77%) 
Reproductive system and breast disorders         
Dysmenorrhoea  1  1/10 (10.00%)  0/10 (0.00%)  0/15 (0.00%)  0/13 (0.00%) 
Hypomenorrhoea  1  0/10 (0.00%)  1/10 (10.00%)  0/15 (0.00%)  0/13 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  0/10 (0.00%)  0/10 (0.00%)  1/15 (6.67%)  0/13 (0.00%) 
Epistaxis  1  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  1/13 (7.69%) 
Nasal congestion  1  0/10 (0.00%)  1/10 (10.00%)  0/15 (0.00%)  0/13 (0.00%) 
Nasal obstruction  1  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  1/13 (7.69%) 
Oropharyngeal pain  1  0/10 (0.00%)  0/10 (0.00%)  1/15 (6.67%)  0/13 (0.00%) 
Rhinorrhoea  1  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  1/13 (7.69%) 
Tonsillar hypertrophy  1  0/10 (0.00%)  0/10 (0.00%)  1/15 (6.67%)  0/13 (0.00%) 
Skin and subcutaneous tissue disorders         
Alopecia  1  1/10 (10.00%)  0/10 (0.00%)  0/15 (0.00%)  0/13 (0.00%) 
Pruritus  1  0/10 (0.00%)  1/10 (10.00%)  0/15 (0.00%)  0/13 (0.00%) 
Rash  1  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  1/13 (7.69%) 
Rash pruritic  1  0/10 (0.00%)  1/10 (10.00%)  0/15 (0.00%)  0/13 (0.00%) 
Skin odour abnormal  1  0/10 (0.00%)  0/10 (0.00%)  0/15 (0.00%)  1/13 (7.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 16.0
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.
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
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01821937     History of Changes
Other Study ID Numbers: 1220.52
First Submitted: March 25, 2013
First Posted: April 1, 2013
Results First Submitted: July 3, 2015
Results First Posted: August 3, 2015
Last Update Posted: August 3, 2015