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Trial record 99 of 115 for:    centurion

Odiparcil For The Prevention Of Venous Thromboembolism

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ClinicalTrials.gov Identifier: NCT00244725
Recruitment Status : Completed
First Posted : October 27, 2005
Results First Posted : May 2, 2017
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double;   Primary Purpose: Prevention
Conditions Deep Vein Thrombosis
Fibrillation, Atrial
Venous Thromboembolism
Pulmonary Embolism
Interventions Drug: Odiparcil
Drug: Warfarin
Drug: Coumadin
Enrollment 961
Recruitment Details Male or female participants >=35 years of age with scheduled for primary elective unilateral total knee arthroplasty were recruited at 82 centers from 13 countries. The study was conducted between 28 September 2005 and 27 September 2006.
Pre-assignment Details A total of 958 participants were randomized into the study. Two participants each from the treatment arm Odiparcil 250 milligram (mg), and Odiparcil 375 mg did not receive the study medication. Therefore, the intent to treat (ITT) population was comprised of 954 participants.
Arm/Group Title Odiparcil MR 250 mg Tablet Odiparcil MR 375 mg Tablet Odiparcil MR 500 mg Tablet Warfarin INR 2.0 to 3.0
Hide Arm/Group Description Eligible participants received Odiparcil modified release (MR) 250 mg tablet at every 12 hours interval (Q12h)for the duration of 10 ± 2 days of double-blind treatment period. Eligible participants received Odiparcil MR 375 mg tablet at Q12h for the duration of 10 ± 2 days of double-blind treatment period. Eligible participants received Odiparcil MR 500 mg tablet at Q12h for the duration of 10 ± 2 days of double-blind treatment period. Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target International Normalized Ratio (INR) of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
Period Title: Overall Study
Started 237 245 239 237
Completed 214 226 215 216
Not Completed 23 19 24 21
Reason Not Completed
Lost to Follow-up             3             4             9             2
Withdrawal by Subject             9             7             7             8
Not meet treatment eligibility criteria             1             2             0             0
Physician Decision             3             0             1             2
Adverse Events             3             1             4             4
Withdrwal by participant             1             0             0             1
Liver function test abnormality             2             0             0             1
Sponsor withdrew the participant             1             0             0             1
Mediciation Error             0             1             0             0
Rehab Refused to allow participantion             0             1             0             0
Headache             0             1             0             0
Received prohibited medication             0             1             0             1
Confirmed venous thromboembolism (VTE)             0             1             0             0
Administrative reason             0             0             1             0
Vomit             0             0             1             0
Failed to follow-up             0             0             1             1
Arm/Group Title Odiparcil MR 250 mg Tablet Odiparcil MR 375 mg Tablet Odiparcil MR 500 mg Tablet Warfarin INR 2.0 to 3.0 Total
Hide Arm/Group Description Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period. Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period. Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period. Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period. Total of all reporting groups
Overall Number of Baseline Participants 235 243 239 237 954
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 235 participants 243 participants 239 participants 237 participants 954 participants
66.1  (9.53) 65.3  (8.93) 64.5  (8.68) 66.1  (9.30) 65.5  (9.12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 235 participants 243 participants 239 participants 237 participants 954 participants
Female
150
  63.8%
156
  64.2%
155
  64.9%
150
  63.3%
611
  64.0%
Male
85
  36.2%
87
  35.8%
84
  35.1%
87
  36.7%
343
  36.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 235 participants 243 participants 239 participants 237 participants 954 participants
African American/African Heritage 18 17 20 12 67
American Indian or Alaska Native 0 0 1 0 1
Asian - Central/South Asian Heritage 3 1 3 3 10
Asian - East Asian Heritage 0 1 1 0 2
Asian - South East Asian Heritage 0 0 0 1 1
White - Arabic/North African Heritage 1 0 1 0 2
White - White/Caucasian/European Heritage 212 224 210 220 866
Mixed Race 1 0 0 1 2
1.Primary Outcome
Title Percentage of Participants With Total VTE Event Over 10 ± 2 Days of Treatment
Hide Description Participants were assessed for VTE at all study visits and at the end of study (Day 10±2) or at early withdrawal. Any participant who remained asymptomatic for VTE at the end of the study did not receive a mandatory bilateral venogram following at least 8 days on study medication. Participants who were withdrawn early and had been objectively confirmed to have a VTE event by a method other than venography were not required to undergo venography. A participant was included in the Independent Central Adjudication Committee (ICAC)-adjudicated incidence of total VTE if he/ she experienced any of adjudicated asymptomatic deep vein thrombosis (DVT) at early withdrawal or after 8-12 days of study treatment and no later than 1 day after end of study treatment, adjudicated symptomatic DVT or pulmonary embolism (PE) at any time during study treatment or death adjudicated to be related to VTE during study treatment.
Time Frame Up to Visit 7 (10 ± 2 days of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population comprised of all participants who were randomized and received at least one dose of study treatment. Total number of participants with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at study completion were used for analysis.
Arm/Group Title Odiparcil MR 250 mg Tablet Odiparcil MR 375 mg Tablet Odiparcil MR 500 mg Tablet Warfarin INR 2.0 to 3.0
Hide Arm/Group Description:
Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
Overall Number of Participants Analyzed 164 169 160 157
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
45.1
(37.4 to 53.1)
44.4
(36.8 to 52.2)
41.3
(33.5 to 49.3)
31.2
(24.1 to 39.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Odiparcil MR 250 mg Tablet, Warfarin INR 2.0 to 3.0
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.45
Confidence Interval (2-Sided) 95%
1.1 to 1.9
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Odiparcil MR 375 mg Tablet, Warfarin INR 2.0 to 3.0
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.42
Confidence Interval (2-Sided) 95%
1.1 to 1.9
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Odiparcil MR 250 mg Tablet, Warfarin INR 2.0 to 3.0
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.080
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.32
Confidence Interval (2-Sided) 95%
1.0 to 1.8
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Proximal DVT Over 10 ± 2 Days of Treatment
Hide Description Proximal DVT is defined as DVT in or above the popliteal vein. A participant was considered to have had an asymptomatic evaluable venogram if the ICAC answer to the DVT question was ‘Yes’ or ‘No’, and to have had an adjudicated asymptomatic DVT if the answer was ‘Yes’. A participant who reported symptoms of DVT was considered to had an adjudicated objectively confirmed symptomatic DVT if the ICAC answer to the question ‘Was a symptomatic DVT identified?’ was ‘Yes’ and the event happened no more than 12 days after start of study treatment (unless exemption for extended treatment was granted by the medical monitor) and no more than 1 day after end of study treatment. In both asymptomatic and symptomatic DVT, the participant was considered to had a proximal DVT if either of the ICAC answers to the questions ‘Left proximal’ and ‘Right proximal’ was ‘DVT’. Percentage of participants with proximal DVT over 10 ± 2 days of treatment were reported.
Time Frame Up to 12 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis.
Arm/Group Title Odiparcil MR 250 mg Tablet Odiparcil MR 375 mg Tablet Odiparcil MR 500 mg Tablet Warfarin INR 2.0 to 3.0
Hide Arm/Group Description:
Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
Overall Number of Participants Analyzed 164 169 160 157
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Asymptomatic, Proximal DVT
1.8
(0.4 to 5.3)
1.8
(0.4 to 5.1)
4.4
(1.8 to 8.8)
0.6
(0.0 to 3.5)
Symptomatic, Proximal DVT
0.0
(0.0 to 2.2)
0.0
(0.0 to 2.2)
0.6
(0.0 to 3.4)
0.0
(0.0 to 2.3)
Total, Proximal DVT
1.8
(0.4 to 5.3)
1.8
(0.4 to 5.1)
5.0
(2.2 to 9.6)
0.6
(0.0 to 3.5)
3.Secondary Outcome
Title Percentage of Participants With Distal DVT Over 10 ± 2 Days of Treatment
Hide Description A participant was considered to have had an asymptomatic evaluable venogram if the ICAC answer to the DVT question was ‘Yes’ or ‘No’, and to have had an adjudicated asymptomatic DVT if the answer was ‘Yes’. A participant who reported symptoms of DVT was considered to had an adjudicated objectively confirmed symptomatic DVT if the ICAC answer to the question ‘Was a symptomatic DVT identified?’ was ‘Yes’ and the event happened no more than 12 days after start of study treatment (unless exemption for extended treatment was granted by the medical monitor) and no more than 1 day after end of study treatment. In both asymptomatic and symptomatic DVT, the participant was considered to had a distal DVT if either of the investigator’s answers to the questions ‘Left distal’ and ‘Right distal’ is ‘DVT’.
Time Frame Up to 12 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis.
Arm/Group Title Odiparcil MR 250 mg Tablet Odiparcil MR 375 mg Tablet Odiparcil MR 500 mg Tablet Warfarin INR 2.0 to 3.0
Hide Arm/Group Description:
Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
Overall Number of Participants Analyzed 164 169 160 157
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of paticipants
Asymptomatic, Distal DVT
42.1
(34.4 to 50.0)
43.8
(36.2 to 51.6)
38.8
(31.2 to 46.8)
30.6
(23.5 to 38.4)
Symptomatic, Distal DVT
1.8
(0.4 to 5.3)
0.0
(0.0 to 2.2)
0.6
(0.0 to 3.4)
0.0
(0.0 to 2.3)
Total, Distal DVT
43.9
(36.2 to 51.9)
43.8
(36.2 to 51.6)
39.4
(31.8 to 47.4)
30.6
(23.5 to 38.4)
4.Secondary Outcome
Title Percentage of Participants With PE Over 10 ± 2 Days of Treatment
Hide Description Participant who reported symptoms of PE were considered to have had an adjudicated objectively confirmed symptomatic PE if the ICAC answer to the question ‘Was a PE identified?’ was ‘Yes’. E was characterized as fatal PE non-fatal PE and total PE events. Data has been presented for fatal PE non-fatal PE and total PE events over 12 days.
Time Frame Up to 12 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis.
Arm/Group Title Odiparcil MR 250 mg Tablet Odiparcil MR 375 mg Tablet Odiparcil MR 500 mg Tablet Warfarin INR 2.0 to 3.0
Hide Arm/Group Description:
Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
Overall Number of Participants Analyzed 164 169 160 157
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Fatal PE
0.0
(0.0 to 2.2)
0.0
(0.0 to 2.2)
0.0
(0.0 to 2.3)
0.0
(0.0 to 2.3)
Non-fatal PE
1.2
(0.1 to 4.3)
0.6
(0.0 to 3.3)
0.0
(0.0 to 2.3)
0.6
(0.0 to 3.5)
Total PE
1.2
(0.1 to 4.3)
0.6
(0.0 to 3.3)
0.0
(0.0 to 2.3)
0.6
(0.0 to 3.5)
5.Secondary Outcome
Title Number of Death Due to VTE Over 10 ± 2 Days of Treatment
Hide Description A participant was considered dead from an adjudicated VTE-related cause if the death classification was recorded as ‘Fatal PE’. A participant was considered to have died from an investigator-assessed VTE-related cause if the investigator’s death classification was recorded as ‘Fatal PE’. Number of death due to VTE over 10 ± 2 days of treatment were reported.
Time Frame Up to 12 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis.
Arm/Group Title Odiparcil MR 250 mg Tablet Odiparcil MR 375 mg Tablet Odiparcil MR 500 mg Tablet Warfarin INR 2.0 to 3.0
Hide Arm/Group Description:
Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
Overall Number of Participants Analyzed 164 169 160 157
Measure Type: Number
Unit of Measure: Participants
0 0 0 0
6.Secondary Outcome
Title Percentage of Participants With Total Asymptomatic VTE Over 10 ± 2 Days of Treatment
Hide Description A participant was included in the Independent Central Adjudication Committee (ICAC)-adjudicated incidence of total VTE if experienced any of adjudicated asymptomatic deep vein thrombosis (DVT) at early withdrawal or after 8-12 days of study treatment and no later than 1 day after end of study treatment, adjudicated symptomatic DVT or PE at any time during study treatment or death adjudicated to be related to VTE during study treatment. A participant was considered to have had an asymptomatic evaluable venogram if the ICAC answer to the DVT question was ‘Yes’ or ‘No’, and to have had an adjudicated asymptomatic DVT if the answer was ‘Yes’. The participant was considered to had a proximal DVT if either of the investigator’s answers to the questions ‘Left distal’ and ‘Right distal’ is ‘DVT’. The participant was considered to had a distal DVT if either of the investigator’s answers to the questions ‘Left distal’ and ‘Right distal’ is ‘DVT’.
Time Frame Up to 12 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis.
Arm/Group Title Odiparcil MR 250 mg Tablet Odiparcil MR 375 mg Tablet Odiparcil MR 500 mg Tablet Warfarin INR 2.0 to 3.0
Hide Arm/Group Description:
Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
Overall Number of Participants Analyzed 164 169 160 157
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
42.1
(34.4 to 50.0)
43.8
(36.2 to 51.6)
40.0
(32.3 to 48.0)
30.6
(23.5 to 38.4)
7.Secondary Outcome
Title Percentage of Total Symptomatic VTE Over 10 ± 2 Days of Treatment
Hide Description A participant who reported symptoms of DVT was considered to had an adjudicated objectively confirmed symptomatic DVT if the ICAC answer to the question ‘Was a symptomatic DVT identified?’ was ‘Yes’ and the event happened no more than 12 days after start of study treatment (unless exemption for extended treatment was granted by the medical monitor) and no more than 1 day after end of study treatment. The participant was considered to had a proximal DVT if either of the investigator’s answers to the questions ‘Left distal’ and ‘Right distal’ was ‘DVT’. The participant was considered to had a distal DVT if either of the investigator’s answers to the questions ‘Left distal’ and ‘Right distal’ was ‘DVT’. Percentage of participants with total symptomatic (distal and proximal) VTE over 10 ± 2 days of treatment were reported.
Time Frame Up to 12 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis.
Arm/Group Title Odiparcil MR 250 mg Tablet Odiparcil MR 375 mg Tablet Odiparcil MR 500 mg Tablet Warfarin INR 2.0 to 3.0
Hide Arm/Group Description:
Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
Overall Number of Participants Analyzed 164 169 160 157
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Perentage of participants
1.8
(0.4 to 5.3)
0.0
(0.0 to 2.2)
1.3
(0.2 to 4.4)
0.0
(0.0 to 2.3)
8.Secondary Outcome
Title Concentration of Trough Anti-IIa Activity Over the Duration of Treatment and Follow-up
Hide Description In all participants, additional 3 milliliter of blood was collected at the time of other blood sampling as follow: Baseline, Day 3 (predose, 2, 4, 8, 10, and 12 hours post dose), Day 5 (predose), and Day 10 (predose) or early withdrawal from study medication for the assessment of anti-factor IIa activity. Samples were collected in 3.8% sodium citrate tubes and immediately chilled in ice. Plasma were centrifuged and frozen at approximately -20ºC until time of shipment to the regional central laboratory. Concentration of Trough Anti-IIa Activity over the duration of treatment and follow-up were reported.
Time Frame Up to 68 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Odiparcil MR 250 mg Tablet Odiparcil MR 375 mg Tablet Odiparcil MR 500 mg Tablet Warfarin INR 2.0 to 3.0
Hide Arm/Group Description:
Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
Overall Number of Participants Analyzed 235 243 239 237
Geometric Mean (Standard Deviation)
Unit of Measure: Microgram per millilitre (mcg/ml)
Day 3, n= 224, 221, 223, 220 2.44  (1.944) 3.15  (2.667) 3.75  (2.702) 0.26  (0.041)
Day 5, n= 201, 207, 215, 203 1.73  (1.456) 2.43  (1.924) 3.07  (2.440) 0.27  (0.099)
Day 10, n= 179, 197, 199, 181 1.45  (1.298) 2.23  (1.830) 2.45  (2.042) 0.25  (0.020)
Early Withdraw On-therapy, n= 13, 8, 10, 17 1.73  (1.286) 3.73  (2.684) 2.49  (3.072) 0.29  (0.159)
14 Day FU, n= 16, 11, 5, 9 0.95  (1.086) 1.16  (1.431) 1.02  (1.652) 0.30  (0.109)
Early Withdraw 14 Day FU, n= 13, 15, 6, 13 0.46  (0.376) 0.74  (0.767) 0.60  (0.666) 0.25  (0.008)
28 Day FU, n= 0, 1, 0, 1 NA [1]   (NA) 0.25 [2]   (NA) NA [1]   (NA) 0.25 [2]   (NA)
Early Withdraw 28 Day FU, n=0, 1, 0, 1 NA [1]   (NA) 0.25 [2]   (NA) NA [1]   (NA) 0.25 [2]   (NA)
[1]
Participants were not analyzed at this time point.
[2]
Standard deviation was not derived as only one participant was available at the time of analysis analyzed.
9.Secondary Outcome
Title Percentage of Participants With Major Bleeds Over 10 ± 2 Days of Treatment
Hide Description A participant was included in the ICAC-adjudicated incidence of major bleeding if participant experienced an adjudicated major bleed up to 12 days after the start of study treatment and no later than 1 day after end of study treatment. Major bleed was defined as clinically overt bleeding, 1) Clinical overt bleeding: clinically apparent bleeding or signs and/or symptoms suggestive of bleeding with confirmatory imaging studies (e.g., ultrasound, computed tomography) 2. Critical Site Involvement: Intracranial, retroperitoneal, intra-ocular, intraspinal, pericardial. 3. Decrease in Hgb > 2 g/dL from baseline, 4. Transfusion of > 2 units of packed RBCs, 5. Medical or Surgical Intervention for the Reported Bleed, 6. Fatal Bleed. If the event satisfied one of the above criteria.
Time Frame Up to 12 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. The participants from ITT population who completed study treatment (Day-10 visit) or reported a major bleed by the time of early withdrawal were used for the analysis
Arm/Group Title Odiparcil MR 250 mg Tablet Odiparcil MR 375 mg Tablet Odiparcil MR 500 mg Tablet Warfarin INR 2.0 to 3.0
Hide Arm/Group Description:
Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
Overall Number of Participants Analyzed 205 217 222 203
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0.0
(0.0 to 1.8)
0.0
(0.0 to 1.7)
0.9
(0.1 to 3.2)
1.0
(0.1 to 3.5)
10.Secondary Outcome
Title Percentage of Participants With VTE and/or Major Bleeding Over 10±2 Days of Treatment
Hide Description A participant was included in the ICAC-adjudicated incidence of major bleeding if experienced an adjudicated major bleed up to 12 days after the start of study treatment and no later than 1 day after end of study treatment. Percentage of participants with VTE and/or major bleeding over 10±2 days of treatment were reported.
Time Frame Up to 12 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The participants from ITT population who were efficacy evaluable or reported a major bleed or VTE by the time of early withdrawal were used for the analysis
Arm/Group Title Odiparcil MR 250 mg Tablet Odiparcil MR 375 mg Tablet Odiparcil MR 500 mg Tablet Warfarin INR 2.0 to 3.0
Hide Arm/Group Description:
Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
Overall Number of Participants Analyzed 164 169 160 157
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
VTE and/or major bleed
45.1
(37.4 to 53.1)
44.4
(36.8 to 52.2)
42.5
(34.7 to 50.6)
32.5
(25.2 to 40.4)
VTE and major bleed
0.0
(0.0 to 2.2)
0.0
(0.0 to 2.2)
0.0
(0.0 to 2.3)
0.0
(0.0 to 2.3)
VTE with no major bleed
45.1
(37.4 to 53.1)
44.4
(36.8 to 52.2)
41.3
(33.5 to 49.3)
31.2
(24.1 to 39.1)
Major bleed with no VTE
0.0
(0.0 to 2.2)
0.0
(0.0 to 2.2)
1.3
(0.2 to 4.4)
1.3
(0.2 to 4.5)
No VTE and no major bleed
54.9
(46.9 to 62.6)
55.6
(47.8 to 63.2)
58.1
(50.1 to 65.9)
68.2
(60.3 to 75.4)
11.Secondary Outcome
Title Percentage of Participants With Total VTE Any Time After Start of Treatment
Hide Description Participants were assessed for VTE at all study visits and at the end of the study (Day 10±2) or at early withdrawal. Any participant who remained asymptomatic for VTE at the end of the study were received a mandatory bilateral venogram. Participants who were withdrawn early and had been objectively confirmed to have a VTE event by a method other than venography were not required to undergo venography. A participant was included in the ICAC-adjudicated incidence of total VTE if experienced any of adjudicated asymptomatic DVT at early withdrawal or after 8-12 days of study treatment and no later than 1 day after end of study treatment, adjudicated symptomatic DVT or PE at any time during study treatment or death adjudicated to be related to VTE during study treatment. Percentage of participants with total VTE any time after start of treatment were reported.
Time Frame Up to Visit 9 (Day 28 post treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis
Arm/Group Title Odiparcil MR 250 mg Tablet Odiparcil MR 375 mg Tablet Odiparcil MR 500 mg Tablet Warfarin INR 2.0 to 3.0
Hide Arm/Group Description:
Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
Overall Number of Participants Analyzed 170 179 171 168
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percenatge of participants
46.5
(38.8 to 54.3)
45.8
(38.4 to 53.4)
43.3
(35.7 to 51.1)
30.4
(23.5 to 37.9)
12.Secondary Outcome
Title Percentage of Participants With Elevated Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Direct Bilirubin (DB) and Total Bilirubin (TB) by 2 Fold and 3 Fold From Upper Normal Limits (ULN) Any Time On-treatment
Hide Description The ranges (low concern value; high concern value) for AST (none; > 3 fold upper normal limit (ULN) ), ALT (none; >3 fold ULN), total bilirubin (none; >= 34.2 micromole per litre [umol/L]), Direct bilirubin (none; >= 34.2 umol/L). Percentage of participants with elevated values by 2 fold and 3 fold from ULN any time on-treatment were reported.
Time Frame Up to 12 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants were available at the time of analysis were included.
Arm/Group Title Odiparcil MR 250 mg Tablet Odiparcil MR 375 mg Tablet Odiparcil MR 500 mg Tablet Warfarin INR 2.0 to 3.0
Hide Arm/Group Description:
Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
Overall Number of Participants Analyzed 231 235 236 234
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
ALT, >=2xULN
4.8
(2.4 to 8.4)
3.8
(1.8 to 7.1)
3.8
(1.8 to 7.1)
5.6
(3.0 to 9.3)
ALT, >=3xULN
0.9
(0.1 to 3.1)
2.6
(0.9 to 5.5)
0.4
(0.0 to 2.3)
2.1
(0.7 to 4.9)
AST, >=2xULN
2.6
(1.0 to 5.6)
3.4
(1.5 to 6.6)
3.8
(1.8 to 7.1)
4.7
(2.4 to 8.3)
AST, >=3xULN
0.0
(0.0 to 1.6)
0.9
(0.1 to 3.1)
0.4
(0.0 to 2.3)
1.7
(0.5 to 4.3)
Total Billirubin, >=2xULN
0.0
(0.0 to 1.6)
0.4
(0.0 to 2.3)
0.4
(0.0 to 2.3)
0.0
(0.0 to 1.6)
Total Billirubin, >=3xULN
0.0
(0.0 to 1.6)
0.0
(0.0 to 1.6)
0.0
(0.0 to 1.6)
0.0
(0.0 to 1.6)
Direct Billirubin, >=2xULN
0.4
(0.0 to 2.4)
0.4
(0.0 to 2.3)
0.4
(0.0 to 2.3)
0.9
(0.1 to 3.1)
Direct Billirubin, >=3xULN
0.4
(0.0 to 2.4)
0.4
(0.0 to 2.3)
0.0
(0.0 to 1.6)
0.0
(0.0 to 1.6)
Time Frame Serious adverse events (SAE) and non-serious adverse events (nSAEs) were collected up to follow-up visit (Visit 9, Day 28±2 days after study medication discontinuation). On-treatment nSAEs were reported.
Adverse Event Reporting Description ITT population was used for analysis.
 
Arm/Group Title ODIPARCIL MR 250 mg Tablet ODIPARCIL MR 375 MG TABLET ODIPARCIL MR 500 MG TABLET WARFARIN INR 2.0 TO 3.0
Hide Arm/Group Description Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period. Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period. Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period. Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
All-Cause Mortality
ODIPARCIL MR 250 mg Tablet ODIPARCIL MR 375 MG TABLET ODIPARCIL MR 500 MG TABLET WARFARIN INR 2.0 TO 3.0
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ODIPARCIL MR 250 mg Tablet ODIPARCIL MR 375 MG TABLET ODIPARCIL MR 500 MG TABLET WARFARIN INR 2.0 TO 3.0
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/235 (5.96%)      11/243 (4.53%)      16/239 (6.69%)      9/237 (3.80%)    
Blood and lymphatic system disorders         
Coagulopathy  1  0/235 (0.00%)  1/243 (0.41%)  0/239 (0.00%)  0/237 (0.00%) 
Cardiac disorders         
Atrial fibrillation  1  1/235 (0.43%)  0/243 (0.00%)  2/239 (0.84%)  0/237 (0.00%) 
Cardiac failure congestive  1  1/235 (0.43%)  0/243 (0.00%)  1/239 (0.42%)  0/237 (0.00%) 
Acute myocardial infarction  1  0/235 (0.00%)  0/243 (0.00%)  0/239 (0.00%)  1/237 (0.42%) 
Atrial flutter  1  1/235 (0.43%)  0/243 (0.00%)  0/239 (0.00%)  0/237 (0.00%) 
Atrial thrombosis  1  1/235 (0.43%)  0/243 (0.00%)  0/239 (0.00%)  0/237 (0.00%) 
Myocardial ischaemia  1  1/235 (0.43%)  0/243 (0.00%)  0/239 (0.00%)  0/237 (0.00%) 
Gastrointestinal disorders         
Ileus paralytic  1  1/235 (0.43%)  0/243 (0.00%)  0/239 (0.00%)  1/237 (0.42%) 
Gastric ulcer haemorrhage  1  0/235 (0.00%)  0/243 (0.00%)  1/239 (0.42%)  0/237 (0.00%) 
Intestinal obstruction  1  0/235 (0.00%)  1/243 (0.41%)  0/239 (0.00%)  0/237 (0.00%) 
General disorders         
Chest pain  1 [1]  1/235 (0.43%)  0/243 (0.00%)  0/239 (0.00%)  0/237 (0.00%) 
Oedema peripheral  1 [1]  0/235 (0.00%)  1/243 (0.41%)  0/239 (0.00%)  0/237 (0.00%) 
Infections and infestations         
Pneumonia  1  1/235 (0.43%)  1/243 (0.41%)  1/239 (0.42%)  0/237 (0.00%) 
Postoperative wound infection  1  1/235 (0.43%)  1/243 (0.41%)  0/239 (0.00%)  0/237 (0.00%) 
Arthritis infective  1  0/235 (0.00%)  0/243 (0.00%)  1/239 (0.42%)  0/237 (0.00%) 
Bronchitis acute  1  1/235 (0.43%)  0/243 (0.00%)  0/239 (0.00%)  0/237 (0.00%) 
Device related infection  1  0/235 (0.00%)  0/243 (0.00%)  1/239 (0.42%)  0/237 (0.00%) 
Diverticulitis  1  0/235 (0.00%)  0/243 (0.00%)  0/239 (0.00%)  1/237 (0.42%) 
Gastroenteritis  1  0/235 (0.00%)  0/243 (0.00%)  0/239 (0.00%)  1/237 (0.42%) 
Infection  1  0/235 (0.00%)  0/243 (0.00%)  1/239 (0.42%)  0/237 (0.00%) 
Influenza  1  0/235 (0.00%)  1/243 (0.41%)  0/239 (0.00%)  0/237 (0.00%) 
Postoperative infection  1  0/235 (0.00%)  1/243 (0.41%)  0/239 (0.00%)  0/237 (0.00%) 
Viral upper respiratory tract infection  1  1/235 (0.43%)  0/243 (0.00%)  0/239 (0.00%)  0/237 (0.00%) 
Injury, poisoning and procedural complications         
Wound dehiscence  1  1/235 (0.43%)  0/243 (0.00%)  2/239 (0.84%)  0/237 (0.00%) 
Fall  1  1/235 (0.43%)  0/243 (0.00%)  0/239 (0.00%)  0/237 (0.00%) 
Joint injury  1  1/235 (0.43%)  0/243 (0.00%)  0/239 (0.00%)  0/237 (0.00%) 
Overdose  1  1/235 (0.43%)  0/243 (0.00%)  0/239 (0.00%)  0/237 (0.00%) 
Patella fracture  1  0/235 (0.00%)  1/243 (0.41%)  0/239 (0.00%)  0/237 (0.00%) 
Post procedural complication  1  0/235 (0.00%)  1/243 (0.41%)  0/239 (0.00%)  0/237 (0.00%) 
Postoperative ileus  1  0/235 (0.00%)  0/243 (0.00%)  0/239 (0.00%)  1/237 (0.42%) 
Traumatic haematoma  1  0/235 (0.00%)  0/243 (0.00%)  0/239 (0.00%)  1/237 (0.42%) 
Investigations         
Bleeding time abnormal  1  1/235 (0.43%)  0/243 (0.00%)  0/239 (0.00%)  0/237 (0.00%) 
Body temperature increased  1  0/235 (0.00%)  0/243 (0.00%)  0/239 (0.00%)  1/237 (0.42%) 
Hepatic enzyme increased  1  0/235 (0.00%)  1/243 (0.41%)  0/239 (0.00%)  0/237 (0.00%) 
Metabolism and nutrition disorders         
Dehydration  1  0/235 (0.00%)  0/243 (0.00%)  0/239 (0.00%)  1/237 (0.42%) 
Hyponatraemia  1  0/235 (0.00%)  0/243 (0.00%)  0/239 (0.00%)  1/237 (0.42%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  1/235 (0.43%)  0/243 (0.00%)  1/239 (0.42%)  0/237 (0.00%) 
Joint swelling  1  1/235 (0.43%)  0/243 (0.00%)  0/239 (0.00%)  0/237 (0.00%) 
Nervous system disorders         
Headache  1  1/235 (0.43%)  0/243 (0.00%)  0/239 (0.00%)  0/237 (0.00%) 
Ischaemic stroke  1  1/235 (0.43%)  0/243 (0.00%)  0/239 (0.00%)  0/237 (0.00%) 
Syncope  1  0/235 (0.00%)  0/243 (0.00%)  1/239 (0.42%)  0/237 (0.00%) 
Transient ischaemic attack  1  0/235 (0.00%)  0/243 (0.00%)  1/239 (0.42%)  0/237 (0.00%) 
Psychiatric disorders         
Confusional state  1  0/235 (0.00%)  1/243 (0.41%)  0/239 (0.00%)  0/237 (0.00%) 
Renal and urinary disorders         
Calculus ureteric  1  0/235 (0.00%)  0/243 (0.00%)  1/239 (0.42%)  0/237 (0.00%) 
Renal failure  1  0/235 (0.00%)  0/243 (0.00%)  1/239 (0.42%)  0/237 (0.00%) 
Reproductive system and breast disorders         
Benign prostatic hyperplasia  1  0/235 (0.00%)  0/243 (0.00%)  1/239 (0.42%)  0/237 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Respiratory failure  1  1/235 (0.43%)  0/243 (0.00%)  0/239 (0.00%)  1/237 (0.42%) 
Dyspnoea  1  0/235 (0.00%)  0/243 (0.00%)  0/239 (0.00%)  1/237 (0.42%) 
Vascular disorders         
Haematoma  1  0/235 (0.00%)  0/243 (0.00%)  1/239 (0.42%)  0/237 (0.00%) 
Haemorrhage  1  0/235 (0.00%)  1/243 (0.41%)  0/239 (0.00%)  0/237 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
[1]
General disorders and administration site conditions
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ODIPARCIL MR 250 mg Tablet ODIPARCIL MR 375 MG TABLET ODIPARCIL MR 500 MG TABLET WARFARIN INR 2.0 TO 3.0
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   124/235 (52.77%)      120/243 (49.38%)      122/239 (51.05%)      104/237 (43.88%)    
Cardiac disorders         
Tachycardia  1  11/235 (4.68%)  12 12/243 (4.94%)  12 19/239 (7.95%)  19 12/237 (5.06%)  12
Gastrointestinal disorders         
Nausea  1  27/235 (11.49%)  28 35/243 (14.40%)  36 40/239 (16.74%)  41 33/237 (13.92%)  36
Constipation  1  29/235 (12.34%)  30 25/243 (10.29%)  25 26/239 (10.88%)  26 29/237 (12.24%)  31
Vomiting  1  19/235 (8.09%)  19 15/243 (6.17%)  15 21/239 (8.79%)  21 13/237 (5.49%)  14
General disorders         
Pyrexia  1  40/235 (17.02%)  42 28/243 (11.52%)  30 29/239 (12.13%)  29 34/237 (14.35%)  34
Oedema peripheral  1  27/235 (11.49%)  30 23/243 (9.47%)  27 28/239 (11.72%)  36 25/237 (10.55%)  35
Injury, poisoning and procedural complications         
Anaemia postoperative  1  20/235 (8.51%)  20 21/243 (8.64%)  21 24/239 (10.04%)  24 19/237 (8.02%)  19
Contusion  1  7/235 (2.98%)  8 13/243 (5.35%)  14 8/239 (3.35%)  10 9/237 (3.80%)  10
Investigations         
Body temperature increased  1  18/235 (7.66%)  20 21/243 (8.64%)  21 13/239 (5.44%)  13 13/237 (5.49%)  13
Musculoskeletal and connective tissue disorders         
Pain in extremity  1  8/235 (3.40%)  9 10/243 (4.12%)  10 13/239 (5.44%)  14 9/237 (3.80%)  11
Nervous system disorders         
Dizziness  1  8/235 (3.40%)  8 9/243 (3.70%)  9 14/239 (5.86%)  16 11/237 (4.64%)  14
Psychiatric disorders         
Insomnia  1  17/235 (7.23%)  18 11/243 (4.53%)  11 16/239 (6.69%)  17 13/237 (5.49%)  13
Skin and subcutaneous tissue disorders         
Pruritus  1  11/235 (4.68%)  11 14/243 (5.76%)  14 10/239 (4.18%)  10 9/237 (3.80%)  9
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00244725     History of Changes
Other Study ID Numbers: ITI101711
First Submitted: October 25, 2005
First Posted: October 27, 2005
Results First Submitted: March 21, 2017
Results First Posted: May 2, 2017
Last Update Posted: May 2, 2017