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Trial record 4 of 4 for:    ACETAMINOPHEN METABOLISM

Acetaminophen or Fluvastatin Compared to Placebo on the Transient Post-Dose Symptoms (PDS) Following an Intravenous (i.v.) Infusion of a Single Dose of Zoledronic Acid 5mg, in Post-menopausal Women With Low Bone Mass

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ClinicalTrials.gov Identifier: NCT00489424
Recruitment Status : Completed
First Posted : June 21, 2007
Results First Posted : September 14, 2009
Last Update Posted : February 18, 2011
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Osteoporosis
Interventions Drug: Placebo
Drug: Acetaminophen
Drug: Fluvastatin
Enrollment 793
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Acetaminophen Fluvastatin
Hide Arm/Group Description 2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period). 2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period). 2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
Period Title: Overall Study
Started 267 264 262
Completed 263 259 257
Not Completed 4 5 5
Reason Not Completed
Adverse Event             3             3             4
Lack of Efficacy             1             0             0
Administrative problems             0             2             1
Arm/Group Title Placebo Acetaminophen Fluvastatin Total
Hide Arm/Group Description 2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period). 2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period). 2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period). Total of all reporting groups
Overall Number of Baseline Participants 267 264 262 793
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 267 participants 264 participants 262 participants 793 participants
Between 45 and 55 years 64 69 67 200
Between 56 and 64 years 102 98 92 292
>=65 years 101 97 103 301
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Female Number Analyzed 267 participants 264 participants 262 participants 793 participants
267 264 262 793
1.Primary Outcome
Title Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature or Use of Rescue Medication.
Hide Description Clinically significant increase in oral body temperature or used rescue medication ibuprofen >= 1 time during the 3-day period after i.v. infusion of zoledronic acid 5 mg. A clinically significant increase in body temperature was defined as an increase of at least 1 degree Celsius from baseline and a mean oral body temperature reading of at least 38.5 degrees Celsius occurring at least once during the 3-day treatment period.
Time Frame 0 - 3 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population.
Arm/Group Title Placebo Acetaminophen Fluvastatin
Hide Arm/Group Description:
2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
Overall Number of Participants Analyzed 267 264 262
Measure Type: Number
Unit of Measure: proportion of patients
Increase in oral body temperature:Yes 0.607 0.398 0.618
Increase in oral body temperature:No 0.39 0.602 0.382
2.Secondary Outcome
Title Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature.
Hide Description Clinically significant increase in oral body temperature >= 1 time during the 3-day period after i.v. infusion of zoledronic acid 5 mg. A clinically significant increase in body temperature was defined as an increase of at least 1 degree Celsius from baseline and a mean oral body temperature reading of at least 38.5 degrees Celsius occurring at least once during the 3-day treatment period.
Time Frame 0 - 3 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population.
Arm/Group Title Placebo Acetaminophen Fluvastatin
Hide Arm/Group Description:
2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
Overall Number of Participants Analyzed 267 264 262
Measure Type: Number
Unit of Measure: proportion of patients
Increase in oral body temperature: Yes 0.105 0.049 0.115
Increase in oral body temperature: No 0.891 0.951 0.885
3.Secondary Outcome
Title Proportion of Patients Who Used Rescue Medication.
Hide Description Patients that took rescue medication >= 1 time during the 3-day period after i.v. infusion of zoledronic acid 5 mg. Patients who experienced severe discomfort after their first home measurements and self-administration of study medication were allowed to take ibuprofen (200 mg tablets every 4-6 hours as needed) as rescue medication while continuing to take their study medication.
Time Frame 0 - 3 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population. One patient who used rescue medication in acetaminophen arm and two patients in fluvastatin arm were not included in analysis due to lack of documentation regarding use and exposure of rescue medication.
Arm/Group Title Placebo Acetaminophen Fluvastatin
Hide Arm/Group Description:
2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
Overall Number of Participants Analyzed 267 264 262
Measure Type: Number
Unit of Measure: proportion of patients
Took rescue medication >= 1 time: Yes 0.573 0.386 0.595
Took rescue medication >= 1 time: No 0.423 0.614 0.405
4.Secondary Outcome
Title Number of Rescue Medication Tablets Taken
Hide Description Patients who experienced severe discomfort after their first home measurements and self-administration of study medication were allowed to take ibuprofen (200 mg tablets every 4-6 hours as needed) as rescue medication while continuing to take their study medication.
Time Frame 0 - 3 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of patients who took rescue medication at least once. One patient in acetaminophen arm was not included in analysis since the number of tablets taken was not recorded.
Arm/Group Title Placebo Acetaminophen Fluvastatin
Hide Arm/Group Description:
2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
Overall Number of Participants Analyzed 153 102 158
Mean (Standard Deviation)
Unit of Measure: tablets
6.3  (4.41) 5.7  (4.73) 6.5  (4.78)
5.Secondary Outcome
Title Time to First Rescue Medication After Infusion of Zoledronic Acid 5 mg.
Hide Description Patients who experienced severe discomfort after their first home measurements and self-administration of study medication were allowed to take ibuprofen (200 mg tablets every 4-6 hours as needed) as rescue medication while continuing to take their study medication.
Time Frame 0 - 3 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of patients who took rescue medication at least once. Two patients who took rescue medication in fluvastatin arm were not included in analysis since the time rescue medication was taken was not recorded.
Arm/Group Title Placebo Acetaminophen Fluvastatin
Hide Arm/Group Description:
2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
Overall Number of Participants Analyzed 153 103 156
Mean (Standard Deviation)
Unit of Measure: hours
21.9  (12.21) 28.2  (18.15) 19.9  (40.95)
6.Secondary Outcome
Title Proportion of Patients With a Major Increase (Worsening) in Severity of Questionnaire Symptoms.
Hide Description A major increase (worsening) in severity was defined as an increase in severity of 2 units or more from baseline at least once during the 3 days immediately following i.v. infusion of zoledronic acid 5 mg. The severity of the symptom was evaluated using a 4-point categorical scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe).
Time Frame 0 - 3 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population.
Arm/Group Title Placebo Acetaminophen Fluvastatin
Hide Arm/Group Description:
2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
Overall Number of Participants Analyzed 267 264 262
Measure Type: Number
Unit of Measure: proportion of patients
Feeling feverish 0.395 0.235 0.397
Headache 0.391 0.254 0.439
Aches and pains of muscles/joints 0.477 0.337 0.462
7.Secondary Outcome
Title Proportion of Patients Reporting Severe Questionnaire Symptoms.
Hide Description A severe questionnaire symptom was defined as experiencing a severe specified symptom (feeling feverish, experiencing headaches, having aches and pains of muscles and joints) at least once post-baseline.
Time Frame 0 - 3 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population.
Arm/Group Title Placebo Acetaminophen Fluvastatin
Hide Arm/Group Description:
2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
Overall Number of Participants Analyzed 267 264 262
Measure Type: Number
Unit of Measure: proportion of patients
Feeling feverish 0.135 0.076 0.145
Headache 0.157 0.068 0.160
Aches and pains of muscles/joints 0.303 0.212 0.302
8.Secondary Outcome
Title Change From Baseline in Visual Analog Scale (VAS) Measurement of Symptom Severity
Hide Description Effect on severity of symptoms following i.v. infusion of zoledronic acid 5 mg. The VAS is a 100-mm linear visual analog scale (0 = no symptoms to 100 = severe symptoms). The baseline VAS measurement was defined as the VAS measurement recorded prior to the infusion.
Time Frame 0 - 3 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population. Number of participants analyzed may vary from ITT population due to some patients not reporting baseline or post baseline VAS measurement. Calculating change requires both baseline and post baseline values to be present.
Arm/Group Title Placebo Acetaminophen Fluvastatin
Hide Arm/Group Description:
2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
Overall Number of Participants Analyzed 267 264 262
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change from baseline to Day 1 - late evening 7.6  (22.74) 4.4  (18.00) 6.0  (18.89)
Change from baseline to Day 2 - late evening 18.9  (25.86) 11.8  (23.22) 20.8  (27.18)
Change from baseline to Day 3 - late evening 6.2  (19.66) 3.9  (17.59) 6.6  (20.40)
Time Frame At the end of study
Adverse Event Reporting Description Safety Population
 
Arm/Group Title Placebo Acetaminophen Fluvastatin
Hide Arm/Group Description 2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period). 2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period). 2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
All-Cause Mortality
Placebo Acetaminophen Fluvastatin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Acetaminophen Fluvastatin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/267 (0.37%)   2/264 (0.76%)   2/262 (0.76%) 
Eye disorders       
Uveitis  1  0/267 (0.00%)  0/264 (0.00%)  1/262 (0.38%) 
General disorders       
Pyrexia  1  0/267 (0.00%)  0/264 (0.00%)  1/262 (0.38%) 
Metabolism and nutrition disorders       
Hypokalaemia  1  1/267 (0.37%)  0/264 (0.00%)  0/262 (0.00%) 
Nervous system disorders       
Convulsion  1  0/267 (0.00%)  0/264 (0.00%)  1/262 (0.38%) 
Syncope  1  0/267 (0.00%)  1/264 (0.38%)  0/262 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pleuritic pain  1  0/267 (0.00%)  1/264 (0.38%)  0/262 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.X
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Acetaminophen Fluvastatin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   34/267 (12.73%)   39/264 (14.77%)   36/262 (13.74%) 
Gastrointestinal disorders       
Nausea  1  7/267 (2.62%)  16/264 (6.06%)  8/262 (3.05%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  13/267 (4.87%)  9/264 (3.41%)  14/262 (5.34%) 
Myalgia  1  14/267 (5.24%)  11/264 (4.17%)  10/262 (3.82%) 
Nervous system disorders       
Headache  1  8/267 (3.00%)  14/264 (5.30%)  15/262 (5.73%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.X
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 terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00489424     History of Changes
Other Study ID Numbers: CZOL446HUS136
First Submitted: June 19, 2007
First Posted: June 21, 2007
Results First Submitted: August 6, 2009
Results First Posted: September 14, 2009
Last Update Posted: February 18, 2011