PK/PD, Long-term Safety and Efficacy of Tamsulosin Treatment in Children With Neurogenic Bladder - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Bladder, Neurogenic
Intervention:	Drug: tamsulosin hydrochloride

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This trial has 3 different Data base locks (DBLs) based on 3 separate populations PK/PD, Group D-Denovo & Group D-527.51 Rollover. For population PK/PD the DBL date was 18July2007, Group D-Denovo the DBL date was 23Jan2009 & Group D-527.51 Rollover the DBL date was 11Sep2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Three different Clinical trial reports were prepared based on 3 separate populations (PK/PD, Group D-Denovo & Group D-527.51). Group D-Denovo includes patients from PK Phase & additional subjects & Group D-527.51 Rollover includes patients who successfully completed tamsulosin HCl Study 527.51

Reporting Groups

	Description
Tamsulosin - Low Dose Level (PK Study)	Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
Tamsulosin - Medium Dose Level (PK Study)	Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
Tamsulosin - High Dose Level (PK Study)	Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight. In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd,body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
Tamsulosin - Low Dose Level (Group D-Denovo)	Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
Tamsulosin - Medium Dose Level (Group D-Denovo)	Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
Tamsulosin - High Dose Level (Group D-Denovo)	Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1- 100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
Tamsulosin - Low Dose Level (Group D-527.51 Rollover)	Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)	Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
Tamsulosin - High Dose Level (Group D-527.51 Rollover)	Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Participant Flow for 2 periods

Period 1: PK Study

	Tamsulosin - Low Dose Level (PK Study)	Tamsulosin - Medium Dose Level (PK Study)	Tamsulosin - High Dose Level (PK Study)
STARTED	10	10	11
COMPLETED	10	9	10
NOT COMPLETED	0	1	1
Adverse Event	0	1	0
Not treated	0	0	1

Period 2: Group D- Denovo & 527.51 Rollover Study

	Tamsulosin - Low Dose Level (Group D-Denovo)	Tamsulosin - Medium Dose Level (Group D-Denovo)	Tamsulosin - High Dose Level (Group D-Denovo)	Tamsulosin - Low Dose Level (Group D-527.51 Rollover)	Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)	Tamsulosin - High Dose Level (Group D-527.51 Rollover)
STARTED	29	21	37	54	13	29
PK Study Subjects Entered Group D-Denovo	7	5	18	0	0	0
COMPLETED	27	16	30	1	1	0
NOT COMPLETED	2	5	7	53	12	29
Adverse Event	2	4	0	0	1	1
Protocol Violation	0	0	1	0	0	0
Withdrawal by Subject	0	1	3	0	0	0
Other reason not defined above	0	0	3	53	11	28

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Set: Includes all patients who are dispensed study medication and are documented to have taken at least one dose of treatment. In this study, some of the subjects are in multiple phases: PK and Group D-Denovo. Thus, the baseline characteristics are based on the unique subject entered into the study.

Reporting Groups

	Description
Tamsulosin - Low Dose Level (PK Study)	Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
Tamsulosin - Medium Dose Level (PK Study)	Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
Tamsulosin - High Dose Level (PK Study)	Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight. In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd,body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
Tamsulosin - Low Dose Level (Group D-Denovo)	Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
Tamsulosin - Medium Dose Level (Group D-Denovo)	Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
Tamsulosin - High Dose Level (Group D-Denovo)	Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
Tamsulosin - Low Dose Level (Group D-527.51 Rollover)	Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)	Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
Tamsulosin - High Dose Level (Group D-527.51 Rollover)	Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
Total	Total of all reporting groups

Baseline Measures

	Tamsulosin - Low Dose Level (PK Study)	Tamsulosin - Medium Dose Level (PK Study)	Tamsulosin - High Dose Level (PK Study)	Tamsulosin - Low Dose Level (Group D-Denovo)	Tamsulosin - Medium Dose Level (Group D-Denovo)	Tamsulosin - High Dose Level (Group D-Denovo)	Tamsulosin - Low Dose Level (Group D-527.51 Rollover)	Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)	Tamsulosin - High Dose Level (Group D-527.51 Rollover)	Total
Number of Participants [units: participants]	10	10	10	22	16	19	54	13	29	183
Age [units: years] Mean (Standard Deviation)	8.7 (4.5)	6.5 (2.6)	8.8 (3.7)	6.8 (3.4)	6.3 (3.7)	8.1 (3.8)	8.1 (3.8)	7.0 (3.4)	8.3 (4.1)	7.7 (3.7)
Gender [units: Subjects]
Female	5	3	5	12	7	10	21	8	12	83
Male	5	7	5	10	9	9	33	5	17	100

Outcome Measures

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1. Primary:

Percentage of LPP Responders for Group D-Denovo and Group D-527.51 Rollover [ Time Frame: Group D-Denovo: Week 52. Group D-527.51 Rollover: Week 1, Week 2, Week 3 and Week 4 prior to dose administration and Week9 (optional), Week 13 (additional), Week 26 (optional) and Week 52 after drug administration. ]

Show Outcome Measure 1

2. Primary:

Number of LPP Responders at Each Visit Over Time (Classified by Last Value on Treatment) for Group D-527.51 Rollover. [ Time Frame: Week 1 (Visit 3) , Week 2 (Visit 4) , Week 3 (Visit 5) and Week 4 (Visit 6) prior to dose administration and Week 9 (Visit 7) (optional), Week 13 (Visit 8) (additional), Week 26 (Visit 9) (optional) and Week 52 (Visit 11) after drug administration. ]

Show Outcome Measure 2

3. Secondary:

Early Responders Who Maintained Their LPP Below 40 cm H2O During the Study for Group D-Denovo and Group D-527.51 Rollover [ Time Frame: Week 1 to Week 52 (Time frame for all weeks are described study wise in the Description). ]

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4. Secondary:

Change From Baseline in LPP for Group D-527.51 Rollover [ Time Frame: Baseline and week 1 ]

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5. Secondary:

Percent Change From Baseline in LPP for Group D-527.51 Rollover [ Time Frame: Baseline and Week 1 ]

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6. Secondary:

Response Defined as Stabilization or Improvement of Hydroureter Measured by Renal Ultrasound Compared to Baseline for Group D-Denovo and Group D-527.51 Rollover [ Time Frame: Group D-Denovo: Baseline and Week 52. Group D-527.51 Rollover: Baseline, Week 26 and Week 52. ]

Show Outcome Measure 6

7. Secondary:

Response Defined as Stabilization or Improvement of Hydronephrosis Measured by Renal Ultrasound Compared to Baseline for Group D-Denovo and Group D-527.51 Rollover [ Time Frame: Group D-Denovo: Baseline and Week 52. Group D-527.51 Rollover: Baseline, Week 26 and Week 52. ]

Show Outcome Measure 7

8. Secondary:

LPP Response at Any Time During the Trial for Group D-Denovo and Group D-527.51 Rollover [ Time Frame: Week 1 to Week 52 (described study wise in the Description). ]

Show Outcome Measure 8

9. Secondary:

Number of Participants With Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic Testing, Electrocardiogram (ECG), Laboratory Values,Urinalysis,Occurence of Adverse Events & Cognitive Testing for Group D-527.51 Rollover [ Time Frame: From first drug administration until 28 days after last study drug administration, upto 395 days ]

Show Outcome Measure 9

10. Secondary:

Number of Participants With Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic Testing, Electrocardiogram (ECG), Laboratory Values, Urinalysis, Occurence of Adverse Events and Cognitive Testing for Group D-Denovo [ Time Frame: From first drug administration until 28 days after last study drug administration, upto 450 days ]

Show Outcome Measure 10

11. Secondary:

Vision Testing for Group D-Denovo [ Time Frame: Baseline, Week 26 and Week 52. ]

Show Outcome Measure 11

12. Secondary:

Vision Testing for Group D-527.51 Rollover [ Time Frame: Baseline and Week 52 ]

Show Outcome Measure 12

13. Secondary:

Cmax,1 [ Time Frame: −0.25h prior to dose and 2h, 4h, 6h and 8h after the drug administration. ]

Show Outcome Measure 13

14. Secondary:

Tmax, 1 [ Time Frame: −0.25h prior to dose and 2h, 4h, 6h and 8h after the drug administration. ]

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15. Secondary:

Cmax, 1 ,DW ,Norm [ Time Frame: −0.25h prior to dose and 2h, 4h, 6h and 8h after the drug administration. ]

Show Outcome Measure 15

16. Secondary:

Cpre,ss [ Time Frame: −0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration. ]

Show Outcome Measure 16

17. Secondary:

Cmax,ss [ Time Frame: −0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration. ]

Show Outcome Measure 17

18. Secondary:

Cmax,ss, DW, Norm [ Time Frame: −0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration. ]

Show Outcome Measure 18

19. Secondary:

Cmin,ss [ Time Frame: −0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration. ]

Show Outcome Measure 19

20. Secondary:

Tmax,ss [ Time Frame: −0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration. ]

Show Outcome Measure 20

21. Secondary:

AUCτ,ss [ Time Frame: −0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration. ]

Show Outcome Measure 21

22. Secondary:

AUCτ ,ss ,DW ,Norm [ Time Frame: −0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration. ]

Show Outcome Measure 22

23. Secondary:

λz,ss [ Time Frame: −0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration. ]

Show Outcome Measure 23

24. Secondary:

t1/2,ss [ Time Frame: −0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration. ]

Show Outcome Measure 24

25. Secondary:

MRTpo,ss [ Time Frame: −0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration. ]

Show Outcome Measure 25

26. Secondary:

CL/F,ss,W,Norm [ Time Frame: −0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration. ]

Show Outcome Measure 26

27. Secondary:

Vz/F,ss,W,Norm [ Time Frame: −0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration. ]

Show Outcome Measure 27

28. Secondary:

RA,Cmax [ Time Frame: −0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration. ]

Show Outcome Measure 28

Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
In Group D-527.51 Rollover study, due to the early termination caution should be used in interpreting these results due to the impact of the early termination, as well as the impact of the study design on interpretation of results by dose.

More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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
e-mail: clintriage.rdg@boehringer-ingelheim.com

Responsible Party:	Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT00340704 History of Changes
Other Study ID Numbers:	527.66
Study First Received:	June 19, 2006
Results First Received:	August 10, 2015
Last Updated:	January 20, 2016
Health Authority:	United States: Food and Drug Administration Belgium: Federal Agency for Medicinal Products and Health Products Brazil: Ministry of Health Canada: Canadian Institutes of Health Research Germany: Federal Institute for Drugs and Medical Devices India: Ministry of Health Italy: Ministry of Health Korea: Food and Drug Administration Mexico: Ministry of Health Philippines: Department of Health Russia: Ministry of Health of the Russian Federation South Africa: Department of Health Spain: Ministry of Health Ukraine: Ministry of Health