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Trial record 18 of 333 for:    DABIGATRAN

Relative Bioavailability of Dabigatran Capsules, Pellets and Oral Solution in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02044367
Recruitment Status : Completed
First Posted : January 24, 2014
Results First Posted : April 27, 2015
Last Update Posted : May 20, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy
Intervention Drug: Dabigatran etexilate
Enrollment 54
Recruitment Details  
Pre-assignment Details  
Arm/Group Title T1-T2-R T1-R-T2 T2-T1-R T2-R-T1 R-T1-T2 R-T2-T1
Hide Arm/Group Description T1: pellets on food; T2: granules for reconstitution into solution; R: hard capsule. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water. T1: pellets on food; R: hard capsule; T2: granules for reconstitution into solution. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water. T2: granules for reconstitution into solution; T1: pellets on food; R: hard capsule. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water. T2: granules for reconstitution into solution; R: hard capsule; T1: pellets on food. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water. R: hard capsule; T1: pellets on food; T2: granules for reconstitution into solution. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water. R: hard capsule; T2: granules for reconstitution into solution; T1: pellets on food. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
Period Title: Overall Study
Started 9 9 9 9 9 9
Completed 9 9 9 9 9 9
Not Completed 0 0 0 0 0 0
Arm/Group Title Overall
Hide Arm/Group Description A randomised, open-label, 3-way crossover, multiple dose trial consisting of 3 identical treatment periods of 3 days. Study drug (150 mg dabigatran etexilate) was administrated twice daily on Day 1 and Day 2 and once on Day 3. The dosage forms used were: hard capsule, granules resolved in reconstitution solution and pellets on food. Treatment periods were separated by a washout phase of at least 5 days between last drug administration of one treatment and the first drug administration of the next treatment.
Overall Number of Baseline Participants 54
Hide Baseline Analysis Population Description
The evaluation of demographic and baseline characteristics were performed on the treated set which included all subjects who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants
36.2  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
Female
0
   0.0%
Male
54
 100.0%
1.Primary Outcome
Title Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Total Dabigatran.
Hide Description Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t for total dabigatran.
Time Frame 47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set (PKS) included all treated subjects that provided at least 1 observation for at least 1 primary or secondary PK endpoint without relevant protocol deviations with respect to the statistical evaluation of PK endpoints.
Arm/Group Title T1 (Treatment A) T2 (Treatment B) R (Reference)
Hide Arm/Group Description:

multiple dose of dabigatran (Pellets)

The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.

multiple dose of dabigatran (Granules resolved in reconstitution solution)

The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.

multiple dose of dabigatran (Hard capsule)

The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.

Overall Number of Participants Analyzed 54 54 53
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng∙h/mL
1220
(34.1%)
1160
(27.0%)
893
(46.8%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T1 (Treatment A), R (Reference)
Comments Analysis of variance (ANOVA) on the logarithmic scale was used including effects for ‘sequence’, ‘period’ and ‘treatment’ as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.
Method of Estimation Estimation Parameter gMean Ratio T1/R (%)
Estimated Value 137.01
Confidence Interval (2-Sided) 90%
125.773 to 149.250
Parameter Dispersion
Type: Standard Deviation
Value: 26.8
Estimation Comments The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection T2 (Treatment B), R (Reference)
Comments Analysis of variance (ANOVA) on the logarithmic scale was used including effects for ‘sequence’, ‘period’ and ‘treatment’ as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.
Method of Estimation Estimation Parameter gMean Ratio T2/R (%)
Estimated Value 130.43
Confidence Interval (2-Sided) 90%
119.628 to 142.200
Parameter Dispersion
Type: Standard Deviation
Value: 27.1
Estimation Comments The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).
2.Primary Outcome
Title Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Total Dabigatran.
Hide Description Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t for total dabigatran.
Time Frame 47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set (PKS) included all treated subjects that provided at least 1 observation for at least 1 primary or secondary PK endpoint without relevant protocol deviations with respect to the statistical evaluation of PK endpoints.
Arm/Group Title T1 (Treatment A) T2 (Treatment B) R (Reference)
Hide Arm/Group Description:

multiple dose of dabigatran (Pellets)

The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.

multiple dose of dabigatran (Granules resolved in reconstitution solution)

The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.

multiple dose of dabigatran (Hard capsule)

The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.

Overall Number of Participants Analyzed 54 54 53
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
191
(37.4%)
184
(27.3%)
131
(50.8%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T1 (Treatment A), R (Reference)
Comments Analysis of variance (ANOVA) on the logarithmic scale was used including effects for ‘sequence’, ‘period’ and ‘treatment’ as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.
Method of Estimation Estimation Parameter gMean Ratio T1/R (%)
Estimated Value 146.16
Confidence Interval (2-Sided) 90%
132.217 to 161.576
Parameter Dispersion
Type: Standard Deviation
Value: 31.6
Estimation Comments The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection T2 (Treatment B), R (Reference)
Comments Analysis of variance (ANOVA) on the logarithmic scale was used including effects for ‘sequence’, ‘period’ and ‘treatment’ as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.
Method of Estimation Estimation Parameter gMean Ratio T2/R (%)
Estimated Value 141.06
Confidence Interval (2-Sided) 90%
127.644 to 155.876
Parameter Dispersion
Type: Standard Deviation
Value: 31.5
Estimation Comments The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).
3.Secondary Outcome
Title Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Free Dabigatran.
Hide Description Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t for free dabigatran.
Time Frame 47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set (PKS) included all treated subjects that provided at least 1 observation for at least 1 primary or secondary PK endpoint without relevant protocol deviations with respect to the statistical evaluation of PK endpoints.
Arm/Group Title T1 (Treatment A) T2 (Treatment B) R (Reference)
Hide Arm/Group Description:

multiple dose of dabigatran (Pellets)

The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.

multiple dose of dabigatran (Granules resolved in reconstitution solution)

The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.

multiple dose of dabigatran (Hard capsule)

The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.

Overall Number of Participants Analyzed 54 54 53
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
1000
(35.8%)
958
(27.6%)
727
(50.8%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T1 (Treatment A), R (Reference)
Comments Analysis of variance (ANOVA) on the logarithmic scale was used including effects for ‘sequence’, ‘period’ and ‘treatment’ as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.
Method of Estimation Estimation Parameter gMean Ratio T1/R (%)
Estimated Value 137.61
Confidence Interval (2-Sided) 90%
126.418 to 149.797
Parameter Dispersion
Type: Standard Deviation
Value: 26.5
Estimation Comments The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection T2 (Treatment B), R (Reference)
Comments Analysis of variance (ANOVA) on the logarithmic scale was used including effects for ‘sequence’, ‘period’ and ‘treatment’ as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.
Method of Estimation Estimation Parameter gMean Ratio T2/R (%)
Estimated Value 132.00
Confidence Interval (2-Sided) 90%
120.714 to 144.342
Parameter Dispersion
Type: Standard Deviation
Value: 28.0
Estimation Comments The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).
4.Secondary Outcome
Title Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Free Dabigatran.
Hide Description Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t for free dabigatran.
Time Frame 47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set (PKS) included all treated subjects that provided at least 1 observation for at least 1 primary or secondary PK endpoint without relevant protocol deviations with respect to the statistical evaluation of PK endpoints.
Arm/Group Title T1 (Treatment A) T2 (Treatment B) R (Reference)
Hide Arm/Group Description:

multiple dose of dabigatran (Pellets)

The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.

multiple dose of dabigatran (Granules resolved in reconstitution solution)

The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.

multiple dose of dabigatran (Hard capsule)

The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.

Overall Number of Participants Analyzed 54 54 53
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
157
(37.9%)
154
(27.6%)
106
(55.1%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T1 (Treatment A), R (Reference)
Comments Analysis of variance (ANOVA) on the logarithmic scale was used including effects for ‘sequence’, ‘period’ and ‘treatment’ as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.
Method of Estimation Estimation Parameter gMean Ratio T1/R (%)
Estimated Value 147.80
Confidence Interval (2-Sided) 90%
133.384 to 163.779
Parameter Dispersion
Type: Standard Deviation
Value: 32.4
Estimation Comments The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection T2 (Treatment B), R (Reference)
Comments Analysis of variance (ANOVA) on the logarithmic scale was used including effects for ‘sequence’, ‘period’ and ‘treatment’ as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.
Method of Estimation Estimation Parameter gMean Ratio T2/R (%)
Estimated Value 144.80
Confidence Interval (2-Sided) 90%
130.853 to 160.242
Parameter Dispersion
Type: Standard Deviation
Value: 32.0
Estimation Comments The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).
5.Secondary Outcome
Title Acceptability Rating for Pellets (on Food) and Oral Solution Will be Assessed by Asking the Subjects 1 Multiple Choice Verbal Question.
Hide Description Acceptability question: "Would you accept to take this medication for chronic use?" with 3 possible answers: Yes - No - I am not sure.
Time Frame once on day 3 (48 hours after first dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Treated set including all subjects that provided at least 1 observation for at least 1 of the questions for at least 1 of the test products.
Arm/Group Title T1 (Treatment A) T2 (Treatment B)
Hide Arm/Group Description:
T1: Pellets on food The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for both treatments T1 and T2. All treatments were administered orally with 240 mL of water.
T2: Granules resolved in reconstitution solution The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for both treatments T1 and T2. All treatments were administered orally with 240 mL of water.
Overall Number of Participants Analyzed 53 53
Measure Type: Number
Unit of Measure: participants
Yes 37 29
No 9 17
I am not sure 7 7
6.Secondary Outcome
Title Palatability Rating for Pellets (on Food) and Oral Solution Will be Assessed by Asking the Subjects 1 Multiple Choice Verbal Question.
Hide Description Palatability question: "How do you rank the taste?" with 5 possible answers: Very good - Good - Fair - Acceptable - Not acceptable.
Time Frame once on day 3 (48 hours after first dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Treated set including all subjects that provided at least 1 observation for at least 1 of the questions for at least 1 of the test products.
Arm/Group Title T1 (Treatment A) T2 (Treatment B)
Hide Arm/Group Description:

T1: Pellets on food

The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for both treatments T1 and T2. All treatments were administered orally with 240 mL of water.

T2: Granules resolved in reconstitution solution

The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for both treatments T1 and T2. All treatments were administered orally with 240 mL of water.

Overall Number of Participants Analyzed 53 53
Measure Type: Number
Unit of Measure: participants
Very good 2 0
Good 20 15
Fair 18 17
Acceptable 11 14
Not acceptable 2 7
Time Frame First dose of study drug date/time until the end-of-trial examination (last per protocol visit)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title T1 (Treatment A) T2 (Treatment B) R (Reference)
Hide Arm/Group Description multiple dose of dabigatran (Pellets). The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water. multiple dose of dabigatran (Granules resolved in reconstitution solution) The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water. multiple dose of dabigatran (Hard capsule) The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
All-Cause Mortality
T1 (Treatment A) T2 (Treatment B) R (Reference)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
T1 (Treatment A) T2 (Treatment B) R (Reference)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/54 (0.00%)   0/54 (0.00%)   0/54 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
T1 (Treatment A) T2 (Treatment B) R (Reference)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/54 (3.70%)   3/54 (5.56%)   1/54 (1.85%) 
Nervous system disorders       
Headache  1  2/54 (3.70%)  3/54 (5.56%)  1/54 (1.85%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 17.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02044367     History of Changes
Other Study ID Numbers: 1160.194
2013-002498-23 ( EudraCT Number: EudraCT )
First Submitted: January 22, 2014
First Posted: January 24, 2014
Results First Submitted: April 10, 2015
Results First Posted: April 27, 2015
Last Update Posted: May 20, 2015