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The PRIMO Study: Paricalcitol Capsules Benefits Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease Stage 3/4 (PRIMO)

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ClinicalTrials.gov Identifier: NCT00497146
Recruitment Status : Completed
First Posted : July 6, 2007
Results First Posted : December 23, 2011
Last Update Posted : March 12, 2013
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Chronic Kidney Disease
Left Ventricular Hypertrophy
Interventions Drug: paricalcitol
Drug: placebo
Enrollment 227
Recruitment Details Participants were enrolled in the study at US and ex-US investigative sites. Recruitment began in March 2008 and ended in December 2009. The study population consisted of participants with Stage 3/4 chronic kidney disease who had a diagnosis of left ventricular hypertrophy confirmed by echocardiogram and cardiac magnetic resonance imaging.
Pre-assignment Details  
Arm/Group Title Paricalcitol Placebo
Hide Arm/Group Description Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period. Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Period Title: Treatment Period
Started 115 112
Completed 88 91
Not Completed 27 21
Reason Not Completed
Adverse Event             6             2
Withdrawal by Subject             5             9
Lost to Follow-up             1             3
Required dialysis             4             1
Change in RAAS inhibitor therapy             5             2
Unable to dose reduce per protocol             4             1
Other Reason             2             3
Period Title: Long-term Follow-up Period
Started 65 72
Completed 50 66
Not Completed 15 6
Reason Not Completed
Adverse Event             2             2
Withdrawal by Subject             8             2
Lost to Follow-up             5             1
Other             0             1
Arm/Group Title Paricalcitol Placebo Total
Hide Arm/Group Description Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period. Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period. Total of all reporting groups
Overall Number of Baseline Participants 115 112 227
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 115 participants 112 participants 227 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
56
  48.7%
51
  45.5%
107
  47.1%
>=65 years
59
  51.3%
61
  54.5%
120
  52.9%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 115 participants 112 participants 227 participants
64.3  (11.30) 65.7  (12.20) 65.0  (11.75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 115 participants 112 participants 227 participants
Female
36
  31.3%
33
  29.5%
69
  30.4%
Male
79
  68.7%
79
  70.5%
158
  69.6%
Baseline RAAS Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 115 participants 112 participants 227 participants
Yes 90 87 177
No 25 25 50
[1]
Measure Description: Baseline renin angiotensin-aldosterone system (RAAS) status refers to whether or not (yes/no) the participant was receiving RAAS inhibitor therapy at baseline.
Diabetic Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 115 participants 112 participants 227 participants
Type I 4 1 5
Type II 59 56 115
None 52 55 107
Age at Beginning of Long term Follow-up Period   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 115 participants 112 participants 227 participants
64.6  (11.01) 66.5  (12.09) 65.6  (11.58)
[1]
Measure Description: Age demographics for the long-term follow-up population include data for 65 and 72 participants in the paricalcitol and placebo groups, respectively.
Gender at Beginning of Long term Follow-up Period  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 115 participants 112 participants 227 participants
Female 20 25 45
Male 45 47 92
1.Primary Outcome
Title Change From Baseline in Left Ventricular Mass Index (LVMI) Over 48 Weeks Measured by Cardiac Magnetic Resonance Imaging (MRI)
Hide Description The Central Cardiac MRI Core Laboratory (CCL) interpreted and analyzed all cardiac MRI data. Left Ventricular Mass (LVM) was normalized to the participant's height by the following equation to obtain LVMI: LVM (grams) divided by height (meters)^2.7.
Time Frame Baseline to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat (ITT) population, defined as all randomized participants who took at least one dose of study drug, with available data.
Arm/Group Title Paricalcitol Placebo
Hide Arm/Group Description:
Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Overall Number of Participants Analyzed 82 87
Least Squares Mean (Standard Error)
Unit of Measure: grams/meter^2.7
0.34  (0.248) -0.07  (0.246)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paricalcitol, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.145
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed model includes treatment, visit, gender, baseline RAAS inhibitor use, country, baseline value, and treatment by visit interaction.
2.Secondary Outcome
Title Change in Diastolic Mitral Annular Relaxation Velocity (E')
Hide Description Diastolic mitral annular relaxation velocity (lateral E wave velocity; E') is a measure of diastolic function.
Time Frame Baseline to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population, participants with available data.
Arm/Group Title Paricalcitol Placebo
Hide Arm/Group Description:
Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Overall Number of Participants Analyzed 79 80
Least Squares Mean (Standard Error)
Unit of Measure: centimeters/second
-0.01  (0.314) -0.30  (0.323)
3.Secondary Outcome
Title Change in Ratio of Peak E Wave Velocity to Lateral E Wave Velocity (E/E')
Hide Description The ratio of peak E wave velocity to lateral E wave velocity (E/E') is a measure of diastolic function.
Time Frame Baseline to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population, participants with available data.
Arm/Group Title Paricalcitol Placebo
Hide Arm/Group Description:
Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Overall Number of Participants Analyzed 78 77
Least Squares Mean (Standard Error)
Unit of Measure: ratio
0.16  (0.580) -0.33  (0.601)
4.Secondary Outcome
Title Change in E-wave Deceleration Time (DT)
Hide Description E-wave deceleration time (DT) is a measure of diastolic function.
Time Frame Baseline to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population, participants with available data.
Arm/Group Title Paricalcitol Placebo
Hide Arm/Group Description:
Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Overall Number of Participants Analyzed 82 80
Least Squares Mean (Standard Error)
Unit of Measure: seconds
0.01  (0.004) -0.00  (0.005)
5.Secondary Outcome
Title Change in Isovolumetric Relaxation Time (IVRT)
Hide Description Isovolumetric relaxation time (IVRT) is a measure of diastolic function.
Time Frame Baseline to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population, participants with available data.
Arm/Group Title Paricalcitol Placebo
Hide Arm/Group Description:
Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Overall Number of Participants Analyzed 83 81
Least Squares Mean (Standard Error)
Unit of Measure: seconds
0.00  (0.002) -0.00  (0.002)
6.Secondary Outcome
Title Change in Left Atrial Volume
Hide Description Left atrial volume is a measure of diastolic function.
Time Frame Baseline to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population, participants with available data.
Arm/Group Title Paricalcitol Placebo
Hide Arm/Group Description:
Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Overall Number of Participants Analyzed 82 80
Least Squares Mean (Standard Error)
Unit of Measure: milliliters
-4.94  (1.159) -0.92  (1.193)
7.Secondary Outcome
Title Change in Plasma Triiodothyronine (T3)
Hide Description Plasma triiodothyronine (T3) is a biological and inflammatory marker.
Time Frame Baseline to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population, participants with available data.
Arm/Group Title Paricalcitol Placebo
Hide Arm/Group Description:
Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Overall Number of Participants Analyzed 83 87
Least Squares Mean (Standard Error)
Unit of Measure: nanomoles/liter
0.07  (0.036) 0.12  (0.036)
8.Secondary Outcome
Title Change in Interleukin-6 (IL-6)
Hide Description Interleukin-6 (IL-6) is a biological and inflammatory marker.
Time Frame Baseline to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population, participants with available data.
Arm/Group Title Paricalcitol Placebo
Hide Arm/Group Description:
Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Overall Number of Participants Analyzed 81 85
Least Squares Mean (Standard Error)
Unit of Measure: nanograms/liter
0.27  (0.844) -0.85  (0.847)
9.Secondary Outcome
Title Change in Troponin-T
Hide Description Troponin-T is a biological and inflammatory marker.
Time Frame Baseline to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population, participants with available data.
Arm/Group Title Paricalcitol Placebo
Hide Arm/Group Description:
Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Overall Number of Participants Analyzed 79 88
Least Squares Mean (Standard Error)
Unit of Measure: micrograms/liter
0.01  (0.002) 0.00  (0.002)
10.Secondary Outcome
Title Change in B-type Natriuretic Peptide (BNP)
Hide Description B-type natriuretic peptide (BNP) is a biological and inflammatory marker.
Time Frame Baseline to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population, participants with available data.
Arm/Group Title Paricalcitol Placebo
Hide Arm/Group Description:
Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Overall Number of Participants Analyzed 79 82
Least Squares Mean (Standard Error)
Unit of Measure: log nanograms/liter
0.19  (0.086) 0.35  (0.085)
11.Secondary Outcome
Title Change in High Sensitivity C-reactive Protein (hsCRP)
Hide Description High sensitivity C-reactive protein (hsCRP) is a biological and inflammatory marker.
Time Frame Baseline to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population, participants with available data.
Arm/Group Title Paricalcitol Placebo
Hide Arm/Group Description:
Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Overall Number of Participants Analyzed 83 88
Least Squares Mean (Standard Error)
Unit of Measure: milligrams/liter
1.49  (1.658) 1.06  (1.623)
12.Secondary Outcome
Title Change in Progression of Thoraco-abdominal Aortic Plaque Volume
Hide Description Change from baseline to Week 48 in thoraco-abdominal aortic plaque volume.
Time Frame Baseline to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population, participants with available data.
Arm/Group Title Paricalcitol Placebo
Hide Arm/Group Description:
Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Overall Number of Participants Analyzed 72 72
Least Squares Mean (Standard Error)
Unit of Measure: milliliters
-0.02  (0.002) -0.03  (0.002)
13.Secondary Outcome
Title Change in Progression of Thoraco-abdominal Aortic Wall Volume
Hide Description Change from baseline to Week 48 in thoraco-abdominal aortic wall volume
Time Frame Baseline to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population, participants with available data.
Arm/Group Title Paricalcitol Placebo
Hide Arm/Group Description:
Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Overall Number of Participants Analyzed 75 72
Least Squares Mean (Standard Error)
Unit of Measure: milliliters
-0.07  (0.023) -0.10  (0.024)
14.Secondary Outcome
Title Change in Progression of Aortic Compliance
Hide Description Change from baseline to Week 48 in aortic compliance.
Time Frame Baseline to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population, participants with available data.
Arm/Group Title Paricalcitol Placebo
Hide Arm/Group Description:
Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Overall Number of Participants Analyzed 78 78
Least Squares Mean (Standard Error)
Unit of Measure: 10^-4 cm^2/mmHg
-7.24  (5.011) -5.79  (4.958)
15.Secondary Outcome
Title Change in Progression of Left Ventricular End-systolic Volume Index
Hide Description Change from baseline to Week 48 in left ventricular end-systolic volume index.
Time Frame Baseline to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population, participants with available data.
Arm/Group Title Paricalcitol Placebo
Hide Arm/Group Description:
Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Overall Number of Participants Analyzed 80 85
Least Squares Mean (Standard Error)
Unit of Measure: milliliters/meter^2.7
0.58  (0.420) 0.57  (0.412)
16.Secondary Outcome
Title Change in Progression of Left Ventricular End-diastolic Volume Index
Hide Description Change from baseline to Week 48 in left ventricular end-diastolic volume index.
Time Frame Baseline to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population, participants with available data.
Arm/Group Title Paricalcitol Placebo
Hide Arm/Group Description:
Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Overall Number of Participants Analyzed 82 87
Least Squares Mean (Standard Error)
Unit of Measure: milliliters/meter^2.7
0.30  (0.480) -0.36  (0.478)
17.Secondary Outcome
Title Change in Progression of Left Ventricular Ejection Fraction
Hide Description Change from baseline to Week 48 in left ventricular ejection fraction.
Time Frame Baseline to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population, participants with available data.
Arm/Group Title Paricalcitol Placebo
Hide Arm/Group Description:
Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Overall Number of Participants Analyzed 78 79
Least Squares Mean (Standard Error)
Unit of Measure: percent
0.62  (0.773) -0.54  (0.771)
Time Frame All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period.
Adverse Event Reporting Description AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
 
Arm/Group Title Paricalcitol: Treatment Period Placebo: Treatment Period Paricalcitol: Long-term Follow-up Placebo: Long-term Follow-up
Hide Arm/Group Description Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who received paricalcitol and completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period. Participants who received placebo and completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
All-Cause Mortality
Paricalcitol: Treatment Period Placebo: Treatment Period Paricalcitol: Long-term Follow-up Placebo: Long-term Follow-up
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Paricalcitol: Treatment Period Placebo: Treatment Period Paricalcitol: Long-term Follow-up Placebo: Long-term Follow-up
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   20/115 (17.39%)   20/112 (17.86%)   18/65 (27.69%)   13/72 (18.06%) 
Blood and lymphatic system disorders         
Anaemia  1  1/115 (0.87%)  0/112 (0.00%)  1/65 (1.54%)  0/72 (0.00%) 
Iron deficiency anaemia  1  1/115 (0.87%)  0/112 (0.00%)  0/65 (0.00%)  0/72 (0.00%) 
Autoimmune thrombocytopenia  1  0/115 (0.00%)  0/112 (0.00%)  1/65 (1.54%)  0/72 (0.00%) 
Cardiac disorders         
Cardiac failure  1  0/115 (0.00%)  1/112 (0.89%)  0/65 (0.00%)  0/72 (0.00%) 
Cardiac failure acute  1  1/115 (0.87%)  0/112 (0.00%)  0/65 (0.00%)  0/72 (0.00%) 
Cardiac failure congestive  1  0/115 (0.00%)  2/112 (1.79%)  1/65 (1.54%)  2/72 (2.78%) 
Coronary artery disease  1  0/115 (0.00%)  1/112 (0.89%)  0/65 (0.00%)  0/72 (0.00%) 
Palpitations  1  1/115 (0.87%)  0/112 (0.00%)  0/65 (0.00%)  0/72 (0.00%) 
Angina pectoris  1  0/115 (0.00%)  0/112 (0.00%)  0/65 (0.00%)  1/72 (1.39%) 
Aortic valve disease  1  0/115 (0.00%)  0/112 (0.00%)  0/65 (0.00%)  1/72 (1.39%) 
Atrial fibrillation  1  0/115 (0.00%)  0/112 (0.00%)  0/65 (0.00%)  1/72 (1.39%) 
Atrioventricular block first degree  1  0/115 (0.00%)  0/112 (0.00%)  0/65 (0.00%)  1/72 (1.39%) 
Cardiac arrest  1  0/115 (0.00%)  0/112 (0.00%)  0/65 (0.00%)  1/72 (1.39%) 
Congenital, familial and genetic disorders         
Congenital cystic kidney disease  1  0/115 (0.00%)  0/112 (0.00%)  1/65 (1.54%)  0/72 (0.00%) 
Ear and labyrinth disorders         
Vertigo  1  0/115 (0.00%)  1/112 (0.89%)  0/65 (0.00%)  0/72 (0.00%) 
Meniere's disease  1  0/115 (0.00%)  0/112 (0.00%)  1/65 (1.54%)  0/72 (0.00%) 
Eye disorders         
Angle closure glaucoma  1  0/115 (0.00%)  0/112 (0.00%)  1/65 (1.54%)  0/72 (0.00%) 
Gastrointestinal disorders         
Abdominal discomfort  1  1/115 (0.87%)  0/112 (0.00%)  0/65 (0.00%)  0/72 (0.00%) 
Dyspepsia  1  1/115 (0.87%)  0/112 (0.00%)  0/65 (0.00%)  0/72 (0.00%) 
Lower gastrointestinal haemorrhage  1  0/115 (0.00%)  1/112 (0.89%)  0/65 (0.00%)  0/72 (0.00%) 
Pancreatitis acute  1  0/115 (0.00%)  1/112 (0.89%)  0/65 (0.00%)  0/72 (0.00%) 
Abdominal pain upper  1  0/115 (0.00%)  0/112 (0.00%)  1/65 (1.54%)  0/72 (0.00%) 
Constipation  1  0/115 (0.00%)  0/112 (0.00%)  0/65 (0.00%)  1/72 (1.39%) 
Diarrhoea  1  0/115 (0.00%)  0/112 (0.00%)  1/65 (1.54%)  0/72 (0.00%) 
Functional gastrointestinal disorder  1  0/115 (0.00%)  0/112 (0.00%)  0/65 (0.00%)  1/72 (1.39%) 
Gastrointestinal disorder  1  0/115 (0.00%)  0/112 (0.00%)  0/65 (0.00%)  1/72 (1.39%) 
Rectal haemorrhage  1  0/115 (0.00%)  0/112 (0.00%)  1/65 (1.54%)  1/72 (1.39%) 
Small intestine obstruction  1  0/115 (0.00%)  0/112 (0.00%)  1/65 (1.54%)  0/72 (0.00%) 
General disorders         
Asthenia  1  1/115 (0.87%)  0/112 (0.00%)  0/65 (0.00%)  0/72 (0.00%) 
Chest pain  1  1/115 (0.87%)  3/112 (2.68%)  0/65 (0.00%)  0/72 (0.00%) 
Fatigue  1  1/115 (0.87%)  0/112 (0.00%)  0/65 (0.00%)  0/72 (0.00%) 
Cardiac death  1  0/115 (0.00%)  0/112 (0.00%)  1/65 (1.54%)  0/72 (0.00%) 
Sudden death  1  0/115 (0.00%)  0/112 (0.00%)  0/65 (0.00%)  1/72 (1.39%) 
Hepatobiliary disorders         
Cholelithiasis  1  1/115 (0.87%)  0/112 (0.00%)  0/65 (0.00%)  0/72 (0.00%) 
Bile duct stone  1  0/115 (0.00%)  0/112 (0.00%)  0/65 (0.00%)  1/72 (1.39%) 
Infections and infestations         
Cellulitis  1  0/115 (0.00%)  2/112 (1.79%)  1/65 (1.54%)  0/72 (0.00%) 
Pneumonia  1  1/115 (0.87%)  3/112 (2.68%)  2/65 (3.08%)  0/72 (0.00%) 
Pneumonia fungal  1  1/115 (0.87%)  0/112 (0.00%)  0/65 (0.00%)  0/72 (0.00%) 
Scrotal abscess  1  1/115 (0.87%)  0/112 (0.00%)  0/65 (0.00%)  0/72 (0.00%) 
Oesophageal candidiasis  1  0/115 (0.00%)  0/112 (0.00%)  1/65 (1.54%)  0/72 (0.00%) 
Otitis externa  1  0/115 (0.00%)  0/112 (0.00%)  1/65 (1.54%)  0/72 (0.00%) 
Otitis media  1  0/115 (0.00%)  0/112 (0.00%)  1/65 (1.54%)  0/72 (0.00%) 
Otitis media acute  1  0/115 (0.00%)  0/112 (0.00%)  1/65 (1.54%)  0/72 (0.00%) 
Pyelonephritis  1  0/115 (0.00%)  0/112 (0.00%)  1/65 (1.54%)  0/72 (0.00%) 
Sepsis  1  0/115 (0.00%)  0/112 (0.00%)  1/65 (1.54%)  0/72 (0.00%) 
Injury, poisoning and procedural complications         
Foot fracture  1  0/115 (0.00%)  1/112 (0.89%)  0/65 (0.00%)  0/72 (0.00%) 
Humerus fracture  1  1/115 (0.87%)  0/112 (0.00%)  0/65 (0.00%)  0/72 (0.00%) 
Lower limb fracture  1  0/115 (0.00%)  1/112 (0.89%)  0/65 (0.00%)  0/72 (0.00%) 
Muscle rupture  1  1/115 (0.87%)  0/112 (0.00%)  0/65 (0.00%)  0/72 (0.00%) 
Post procedural haemorrhage  1  0/115 (0.00%)  1/112 (0.89%)  0/65 (0.00%)  0/72 (0.00%) 
Subdural haematoma  1  0/115 (0.00%)  2/112 (1.79%)  1/65 (1.54%)  0/72 (0.00%) 
Bronchitis  1  0/115 (0.00%)  0/112 (0.00%)  0/65 (0.00%)  1/72 (1.39%) 
Arteriovenous fistula site complication  1  0/115 (0.00%)  0/112 (0.00%)  1/65 (1.54%)  0/72 (0.00%) 
Craniocerebral injury  1  0/115 (0.00%)  0/112 (0.00%)  1/65 (1.54%)  0/72 (0.00%) 
Eye injury  1  0/115 (0.00%)  0/112 (0.00%)  1/65 (1.54%)  0/72 (0.00%) 
Fall  1  0/115 (0.00%)  0/112 (0.00%)  0/65 (0.00%)  1/72 (1.39%) 
Femoral neck injury  1  0/115 (0.00%)  0/112 (0.00%)  0/65 (0.00%)  1/72 (1.39%) 
Head injury  1  0/115 (0.00%)  0/112 (0.00%)  0/65 (0.00%)  1/72 (1.39%) 
Joint dislocation  1  0/115 (0.00%)  0/112 (0.00%)  1/65 (1.54%)  0/72 (0.00%) 
Periorbital haematoma  1  0/115 (0.00%)  0/112 (0.00%)  1/65 (1.54%)  0/72 (0.00%) 
Upper limb fracture  1  0/115 (0.00%)  0/112 (0.00%)  1/65 (1.54%)  0/72 (0.00%) 
Investigations         
Blood creatinine increased  1  1/115 (0.87%)  0/112 (0.00%)  0/65 (0.00%)  0/72 (0.00%) 
Blood glucose decreased  1  0/115 (0.00%)  1/112 (0.89%)  0/65 (0.00%)  0/72 (0.00%) 
Metabolism and nutrition disorders         
Dehydration  1  1/115 (0.87%)  0/112 (0.00%)  0/65 (0.00%)  0/72 (0.00%) 
Diabetic foot  1  0/115 (0.00%)  1/112 (0.89%)  0/65 (0.00%)  0/72 (0.00%) 
Gout  1  0/115 (0.00%)  1/112 (0.89%)  0/65 (0.00%)  0/72 (0.00%) 
Hyperglycaemia  1  1/115 (0.87%)  0/112 (0.00%)  0/65 (0.00%)  0/72 (0.00%) 
Hyperkalaemia  1  0/115 (0.00%)  1/112 (0.89%)  0/65 (0.00%)  2/72 (2.78%) 
Hypoglycaemia  1  2/115 (1.74%)  1/112 (0.89%)  0/65 (0.00%)  1/72 (1.39%) 
Diabetes mellitus  1  0/115 (0.00%)  0/112 (0.00%)  1/65 (1.54%)  0/72 (0.00%) 
Diabetic ketoacidosis  1  0/115 (0.00%)  0/112 (0.00%)  1/65 (1.54%)  0/72 (0.00%) 
Fluid overload  1  0/115 (0.00%)  0/112 (0.00%)  0/65 (0.00%)  1/72 (1.39%) 
Tetany  1  0/115 (0.00%)  0/112 (0.00%)  0/65 (0.00%)  1/72 (1.39%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  1/115 (0.87%)  0/112 (0.00%)  0/65 (0.00%)  0/72 (0.00%) 
Dupuytren's contracture  1  1/115 (0.87%)  0/112 (0.00%)  0/65 (0.00%)  0/72 (0.00%) 
Osteoarthritis  1  2/115 (1.74%)  0/112 (0.00%)  0/65 (0.00%)  0/72 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Acute myeloid leukaemia  1  0/115 (0.00%)  0/112 (0.00%)  1/65 (1.54%)  0/72 (0.00%) 
Colon cancer  1  0/115 (0.00%)  0/112 (0.00%)  1/65 (1.54%)  0/72 (0.00%) 
Lung neoplasm  1  0/115 (0.00%)  0/112 (0.00%)  1/65 (1.54%)  0/72 (0.00%) 
Neoplasm malignant  1  0/115 (0.00%)  0/112 (0.00%)  0/65 (0.00%)  1/72 (1.39%) 
Nervous system disorders         
Dizziness  1  1/115 (0.87%)  0/112 (0.00%)  0/65 (0.00%)  0/72 (0.00%) 
Headache  1  0/115 (0.00%)  1/112 (0.89%)  0/65 (0.00%)  0/72 (0.00%) 
Migraine  1  1/115 (0.87%)  0/112 (0.00%)  0/65 (0.00%)  0/72 (0.00%) 
Convulsion  1  0/115 (0.00%)  0/112 (0.00%)  0/65 (0.00%)  1/72 (1.39%) 
Diabetic neuropathy  1  0/115 (0.00%)  0/112 (0.00%)  1/65 (1.54%)  0/72 (0.00%) 
Embolic stroke  1  0/115 (0.00%)  0/112 (0.00%)  0/65 (0.00%)  1/72 (1.39%) 
Intracranial haematoma  1  0/115 (0.00%)  0/112 (0.00%)  1/65 (1.54%)  0/72 (0.00%) 
Post-traumatic epilepsy  1  0/115 (0.00%)  0/112 (0.00%)  1/65 (1.54%)  0/72 (0.00%) 
Renal and urinary disorders         
Nephropathy  1  1/115 (0.87%)  0/112 (0.00%)  0/65 (0.00%)  0/72 (0.00%) 
Renal failure  1  2/115 (1.74%)  0/112 (0.00%)  0/65 (0.00%)  0/72 (0.00%) 
Renal failure acute  1  2/115 (1.74%)  3/112 (2.68%)  0/65 (0.00%)  1/72 (1.39%) 
Renal failure chronic  1  1/115 (0.87%)  1/112 (0.89%)  1/65 (1.54%)  0/72 (0.00%) 
Renal impairment  1  1/115 (0.87%)  0/112 (0.00%)  0/65 (0.00%)  0/72 (0.00%) 
Azotaemia  1  0/115 (0.00%)  0/112 (0.00%)  0/65 (0.00%)  1/72 (1.39%) 
Proteinuria  1  0/115 (0.00%)  0/112 (0.00%)  0/65 (0.00%)  1/72 (1.39%) 
Vesicourteric reflux  1  0/115 (0.00%)  0/112 (0.00%)  1/65 (1.54%)  0/72 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnoea  1  1/115 (0.87%)  2/112 (1.79%)  0/65 (0.00%)  0/72 (0.00%) 
Acute respiratory failure  1  0/115 (0.00%)  0/112 (0.00%)  0/65 (0.00%)  1/72 (1.39%) 
Hypoxia  1  0/115 (0.00%)  0/112 (0.00%)  0/65 (0.00%)  1/72 (1.39%) 
Pickwickian syndrome  1  0/115 (0.00%)  0/112 (0.00%)  1/65 (1.54%)  0/72 (0.00%) 
Pulmonary embolism  1  0/115 (0.00%)  0/112 (0.00%)  2/65 (3.08%)  0/72 (0.00%) 
Pulmonary oedema  1  0/115 (0.00%)  0/112 (0.00%)  0/65 (0.00%)  1/72 (1.39%) 
Vascular disorders         
Aortic dissection  1  0/115 (0.00%)  1/112 (0.89%)  0/65 (0.00%)  1/72 (1.39%) 
Deep vein thrombosis  1  1/115 (0.87%)  0/112 (0.00%)  0/65 (0.00%)  0/72 (0.00%) 
Hypertension  1  1/115 (0.87%)  1/112 (0.89%)  0/65 (0.00%)  0/72 (0.00%) 
Aortic aneurysm  1  0/115 (0.00%)  0/112 (0.00%)  0/65 (0.00%)  1/72 (1.39%) 
Hypertensive emergency  1  0/115 (0.00%)  0/112 (0.00%)  0/65 (0.00%)  1/72 (1.39%) 
Hypotension  1  0/115 (0.00%)  0/112 (0.00%)  1/65 (1.54%)  0/72 (0.00%) 
Venous thrombosis  1  0/115 (0.00%)  0/112 (0.00%)  1/65 (1.54%)  0/72 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0 / 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Paricalcitol: Treatment Period Placebo: Treatment Period Paricalcitol: Long-term Follow-up Placebo: Long-term Follow-up
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   75/115 (65.22%)   68/112 (60.71%)   4/65 (6.15%)   8/72 (11.11%) 
Blood and lymphatic system disorders         
Anaemia  1  7/115 (6.09%)  6/112 (5.36%)  1/65 (1.54%)  0/72 (0.00%) 
Cardiac disorders         
Bradycardia  1  0/115 (0.00%)  4/112 (3.57%)  0/65 (0.00%)  0/72 (0.00%) 
Ear and labyrinth disorders         
Vertigo  1  3/115 (2.61%)  4/112 (3.57%)  0/65 (0.00%)  0/72 (0.00%) 
Gastrointestinal disorders         
Constipation  1  3/115 (2.61%)  1/112 (0.89%)  1/65 (1.54%)  1/72 (1.39%) 
Diarrhoea  1  8/115 (6.96%)  2/112 (1.79%)  0/65 (0.00%)  0/72 (0.00%) 
Dyspepsia  1  5/115 (4.35%)  0/112 (0.00%)  0/65 (0.00%)  0/72 (0.00%) 
Gastrooesophageal reflux disease  1  3/115 (2.61%)  1/112 (0.89%)  0/65 (0.00%)  0/72 (0.00%) 
Nausea  1  8/115 (6.96%)  5/112 (4.46%)  0/65 (0.00%)  0/72 (0.00%) 
Vomiting  1  4/115 (3.48%)  3/112 (2.68%)  0/65 (0.00%)  0/72 (0.00%) 
General disorders         
Asthenia  1  3/115 (2.61%)  2/112 (1.79%)  0/65 (0.00%)  0/72 (0.00%) 
Chest pain  1  3/115 (2.61%)  0/112 (0.00%)  0/65 (0.00%)  0/72 (0.00%) 
Fatigue  1  6/115 (5.22%)  4/112 (3.57%)  0/65 (0.00%)  0/72 (0.00%) 
Oedema peripheral  1  2/115 (1.74%)  12/112 (10.71%)  0/65 (0.00%)  1/72 (1.39%) 
Infections and infestations         
Bronchitis  1  2/115 (1.74%)  3/112 (2.68%)  0/65 (0.00%)  0/72 (0.00%) 
Nasopharyngitis  1  6/115 (5.22%)  7/112 (6.25%)  0/65 (0.00%)  0/72 (0.00%) 
Sinusitis  1  1/115 (0.87%)  3/112 (2.68%)  0/65 (0.00%)  0/72 (0.00%) 
Upper respiratory tract infection  1  6/115 (5.22%)  5/112 (4.46%)  0/65 (0.00%)  0/72 (0.00%) 
Urinary tract infection  1  3/115 (2.61%)  10/112 (8.93%)  0/65 (0.00%)  0/72 (0.00%) 
Injury, poisoning and procedural complications         
Joint sprain  1  0/115 (0.00%)  3/112 (2.68%)  0/65 (0.00%)  0/72 (0.00%) 
Investigations         
Blood creatinine increased  1  4/115 (3.48%)  1/112 (0.89%)  0/65 (0.00%)  0/72 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite  1  3/115 (2.61%)  1/112 (0.89%)  0/65 (0.00%)  0/72 (0.00%) 
Dehydration  1  3/115 (2.61%)  1/112 (0.89%)  0/65 (0.00%)  0/72 (0.00%) 
Diabetes mellitus  1  0/115 (0.00%)  3/112 (2.68%)  0/65 (0.00%)  0/72 (0.00%) 
Gout  1  4/115 (3.48%)  5/112 (4.46%)  0/65 (0.00%)  1/72 (1.39%) 
Hypercalcaemia  1  10/115 (8.70%)  1/112 (0.89%)  0/65 (0.00%)  0/72 (0.00%) 
Hyperkalaemia  1  2/115 (1.74%)  4/112 (3.57%)  1/65 (1.54%)  0/72 (0.00%) 
Hyperphosphataemia  1  4/115 (3.48%)  0/112 (0.00%)  0/65 (0.00%)  0/72 (0.00%) 
Hypoglycaemia  1  4/115 (3.48%)  1/112 (0.89%)  0/65 (0.00%)  0/72 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  2/115 (1.74%)  5/112 (4.46%)  1/65 (1.54%)  1/72 (1.39%) 
Back pain  1  1/115 (0.87%)  4/112 (3.57%)  0/65 (0.00%)  0/72 (0.00%) 
Muscle spasms  1  3/115 (2.61%)  2/112 (1.79%)  0/65 (0.00%)  0/72 (0.00%) 
Pain in extremity  1  3/115 (2.61%)  1/112 (0.89%)  0/65 (0.00%)  0/72 (0.00%) 
Nervous system disorders         
Dizziness  1  6/115 (5.22%)  2/112 (1.79%)  0/65 (0.00%)  1/72 (1.39%) 
Headache  1  5/115 (4.35%)  2/112 (1.79%)  0/65 (0.00%)  0/72 (0.00%) 
Lethargy  1  3/115 (2.61%)  1/112 (0.89%)  0/65 (0.00%)  0/72 (0.00%) 
Paraesthesia  1  2/115 (1.74%)  3/112 (2.68%)  0/65 (0.00%)  0/72 (0.00%) 
Psychiatric disorders         
Insomnia  1  3/115 (2.61%)  5/112 (4.46%)  0/65 (0.00%)  1/72 (1.39%) 
Renal and urinary disorders         
Renal failure chronic  1  4/115 (3.48%)  1/112 (0.89%)  0/65 (0.00%)  0/72 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  5/115 (4.35%)  6/112 (5.36%)  0/65 (0.00%)  1/72 (1.39%) 
Dyspnoea  1  3/115 (2.61%)  1/112 (0.89%)  0/65 (0.00%)  0/72 (0.00%) 
Dyspnoea exertional  1  1/115 (0.87%)  3/112 (2.68%)  0/65 (0.00%)  0/72 (0.00%) 
Skin and subcutaneous tissue disorders         
Pruritus  1  2/115 (1.74%)  4/112 (3.57%)  0/65 (0.00%)  0/72 (0.00%) 
Rash  1  2/115 (1.74%)  3/112 (2.68%)  0/65 (0.00%)  0/72 (0.00%) 
Vascular disorders         
Hypertension  1  11/115 (9.57%)  4/112 (3.57%)  0/65 (0.00%)  1/72 (1.39%) 
Hypotension  1  4/115 (3.48%)  2/112 (1.79%)  0/65 (0.00%)  0/72 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0 / 14.1
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.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00497146     History of Changes
Other Study ID Numbers: M10-030
2007-001689-34 ( EudraCT Number )
First Submitted: July 3, 2007
First Posted: July 6, 2007
Results First Submitted: September 22, 2011
Results First Posted: December 23, 2011
Last Update Posted: March 12, 2013