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Trial record 40 of 116 for:    medullary carcinoma

An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00410761
Recruitment Status : Active, not recruiting
First Posted : December 13, 2006
Results First Posted : March 26, 2012
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Thyroid Cancer
Intervention Drug: ZD6474 (Vandetanib)
Enrollment 437
Recruitment Details First patient enrolled 23 November 2006, last patient enrolled 19 October 2007, cut off date 31 July 2009. 437 patients were enrolled.
Pre-assignment Details  
Arm/Group Title Vandetanib 300 mg Placebo
Hide Arm/Group Description Vandetanib (300 mg daily) Placebo daily
Period Title: Overall Study
Started 231 [1] 100 [1]
Completed 111 [2] 28 [2]
Not Completed 120 72
Reason Not Completed
Adverse Event             29             3
objective disease progression             71             55
Withdrawal by Subject             8             4
Other             12             9
Never received randomised treatment             0             1
[1]
randomised patients
[2]
ongoing study treatment at data cut-off
Arm/Group Title Vandetanib 300 mg Placebo Total
Hide Arm/Group Description Vandetanib (300 mg daily) Placebo daily Total of all reporting groups
Overall Number of Baseline Participants 231 100 331
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 231 participants 100 participants 331 participants
50.7
(18 to 83)
53.4
(26 to 84)
52
(18 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 231 participants 100 participants 331 participants
Female
97
  42.0%
44
  44.0%
141
  42.6%
Male
134
  58.0%
56
  56.0%
190
  57.4%
1.Primary Outcome
Title Progression-Free Survival(PFS)
Hide Description Median time to progression (months) from randomisation until objective disease progression (determined by RECIST assessments) or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Values here are estimated (from a Weibull model) as the medians were not met.
Time Frame RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib 300 mg Placebo
Hide Arm/Group Description:
Vandetanib (300 mg daily)
Placebo daily
Overall Number of Participants Analyzed 231 100
Median (95% Confidence Interval)
Unit of Measure: Months
30.5 [1] 
(NA to NA)
19.2 [1] 
(NA to NA)
[1]
PFS is a time to event endpoint and because the medians were not met in this study there is no appropriate measure of dispersion of the median
2.Secondary Outcome
Title Objective Response Rate (ORR)
Hide Description

The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as defined by RECIST criteria.

The categories for best objective response are CR, PR, stable disease (SD)>= 12 weeks, progressive disease (PD) or NE.

Time Frame RECIST assessments performed at screening (within 3 weeks before randomisation), then every 12 weeks. For patients with objective response of CR or PR, an additional confirmatory scan was performed ≥4 weeks following the date of first response.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib 300 mg Placebo
Hide Arm/Group Description:
Vandetanib (300 mg daily)
Placebo daily
Overall Number of Participants Analyzed 231 100
Measure Type: Number
Unit of Measure: Participants
104 13
3.Secondary Outcome
Title Disease Control Rate (DCR)
Hide Description Disease control rate is defined as the number of patients who achieved disease control at 8 weeks following randomisation. Disease control at 8 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 12 weeks
Time Frame RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib 300 mg Placebo
Hide Arm/Group Description:
Vandetanib (300 mg daily)
Placebo daily
Overall Number of Participants Analyzed 231 100
Measure Type: Number
Unit of Measure: Participants
200 71
4.Secondary Outcome
Title Duration of Response (DoR)
Hide Description Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment). Values are estimated as the medians weren't met
Time Frame RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent
Hide Outcome Measure Data
Hide Analysis Population Description
DoR is a time to event endpoint and because the medians were not met in this study there is no appropriate measure of dispersion of the median
Arm/Group Title Vandetanib 300 mg Placebo
Hide Arm/Group Description:
Vandetanib (300 mg daily)
Placebo daily
Overall Number of Participants Analyzed 104 13
Median (95% Confidence Interval)
Unit of Measure: Months
22.2 [1] 
(NA to NA)
16.3 [1] 
(NA to NA)
[1]
DoR is a time to event endpoint and because the medians were not met in this study there is no appropriate measure of dispersion of the median
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description As data was immature at data cut off, number of death events is quoted
Time Frame Number of deaths since randomisation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib 300 mg Placebo
Hide Arm/Group Description:
Vandetanib (300 mg daily)
Placebo daily
Overall Number of Participants Analyzed 231 100
Measure Type: Number
Unit of Measure: Participants
32 16
6.Secondary Outcome
Title Biochemical Response Calcitonin (CTN)
Hide Description Best biochemical response was calculated from assessments at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for PR or CR were first met. CR and PR being defined according to level of CTN.
Time Frame Blood samples Blood samples for analysis of CTN were taken at screening baseline (average of 0, 1, 4 and 8 hours), then every 4 weeks until discontinuation and 60 day follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib 300 mg Placebo
Hide Arm/Group Description:
Vandetanib (300 mg daily)
Placebo daily
Overall Number of Participants Analyzed 231 100
Measure Type: Number
Unit of Measure: Participants
160 3
7.Secondary Outcome
Title Biochemical Response Carcinoembryonic Antigen (CEA)
Hide Description Best biochemical response was calculated from assessments at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for PR or CR were first met. CR and PR being defined according to level of CEA.
Time Frame Blood samples for analysis of CEA were taken at screening baseline (average of 0, 1, 4 and 8 hours), then every 4 weeks until discontinuation and 60 day follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib 300 mg Placebo
Hide Arm/Group Description:
Vandetanib (300 mg daily)
Placebo daily
Overall Number of Participants Analyzed 231 100
Measure Type: Number
Unit of Measure: Participants
119 2
8.Secondary Outcome
Title Time to Worsening of Pain (TWP)
Hide Description TWP was derived using the worst pain score from brief pain inventory (BPI) and patient reported opioid analgesic use. BPI uses 0 to 10 numeric rating scales asking subjects to rate their pain.
Time Frame During the last week of the screening period (Day -7 to Day 0), the brief pain inventory (BPI) and opioid analgesic use were self-reported once a day for 4 days to establish baseline, then every week during blinded study treatment, up to discontinuation.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib 300 mg Placebo
Hide Arm/Group Description:
Vandetanib (300 mg daily)
Placebo daily
Overall Number of Participants Analyzed 231 100
Measure Type: Number
Unit of Measure: Weeks
7.8 3.3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vandetanib 300 mg Placebo
Hide Arm/Group Description Vandetanib (300 mg daily) Placebo daily
All-Cause Mortality
Vandetanib 300 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vandetanib 300 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   71/231 (30.74%)   13/99 (13.13%) 
Blood and lymphatic system disorders     
Thrombocytopenia  1  1/231 (0.43%)  0/99 (0.00%) 
Cardiac disorders     
Arrhythmia  1  1/231 (0.43%)  0/99 (0.00%) 
Atrial Fibrillation  1  1/231 (0.43%)  0/99 (0.00%) 
Bradycardia  1  1/231 (0.43%)  0/99 (0.00%) 
Cardiac Failure Acute  1  1/231 (0.43%)  0/99 (0.00%) 
Pericardial Effusion  1  0/231 (0.00%)  1/99 (1.01%) 
Pericardial Haemorrhage  1  0/231 (0.00%)  1/99 (1.01%) 
Pericarditis  1  1/231 (0.43%)  0/99 (0.00%) 
Eye disorders     
Glaucoma  1  1/231 (0.43%)  0/99 (0.00%) 
Vision Blurred  1  1/231 (0.43%)  0/99 (0.00%) 
Gastrointestinal disorders     
Diarrhoea  1  5/231 (2.16%)  0/99 (0.00%) 
Abdominal Pain  1  3/231 (1.30%)  0/99 (0.00%) 
Dysphagia  1  2/231 (0.87%)  0/99 (0.00%) 
Vomiting  1  2/231 (0.87%)  0/99 (0.00%) 
Colitis  1  1/231 (0.43%)  0/99 (0.00%) 
Gastritis  1  1/231 (0.43%)  0/99 (0.00%) 
Gastrointestinal Haemorrhage  1  1/231 (0.43%)  1/99 (1.01%) 
Ileus  1  1/231 (0.43%)  0/99 (0.00%) 
Pancreatitis  1  1/231 (0.43%)  0/99 (0.00%) 
Peritonitis  1  1/231 (0.43%)  0/99 (0.00%) 
Pneumatosis Intestinalis  1  1/231 (0.43%)  0/99 (0.00%) 
Small Intestinal Perforation  1  1/231 (0.43%)  0/99 (0.00%) 
General disorders     
Asthenia  1  2/231 (0.87%)  0/99 (0.00%) 
Chest Pain  1  1/231 (0.43%)  0/99 (0.00%) 
Fatigue  1  1/231 (0.43%)  1/99 (1.01%) 
General Physical Health Deterioration  1  1/231 (0.43%)  1/99 (1.01%) 
Mucosal Inflammation  1  1/231 (0.43%)  0/99 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  1  1/231 (0.43%)  0/99 (0.00%) 
Cholelithiasis  1  1/231 (0.43%)  0/99 (0.00%) 
Immune system disorders     
Iodine Allergy  1  0/231 (0.00%)  1/99 (1.01%) 
Infections and infestations     
Pneumonia  1  5/231 (2.16%)  0/99 (0.00%) 
Urinary Tract Infection  1  3/231 (1.30%)  0/99 (0.00%) 
Appendicitis  1  2/231 (0.87%)  0/99 (0.00%) 
Bronchitis  1  2/231 (0.87%)  1/99 (1.01%) 
Diverticulitis  1  2/231 (0.87%)  0/99 (0.00%) 
Sepsis  1  2/231 (0.87%)  0/99 (0.00%) 
Abdominal Wall Abscess  1  1/231 (0.43%)  0/99 (0.00%) 
Gastroenteritis  1  0/231 (0.00%)  1/99 (1.01%) 
Gastroenteritis Bacterial  1  1/231 (0.43%)  0/99 (0.00%) 
Gastroenteritis Viral  1  1/231 (0.43%)  0/99 (0.00%) 
Infected Bites  1  1/231 (0.43%)  0/99 (0.00%) 
Laryngitis  1  1/231 (0.43%)  0/99 (0.00%) 
Pyelonephritis  1  1/231 (0.43%)  0/99 (0.00%) 
Staphylococcal Infection  1  1/231 (0.43%)  0/99 (0.00%) 
Staphylococcal Sepsis  1  1/231 (0.43%)  0/99 (0.00%) 
Tracheitis  1  1/231 (0.43%)  0/99 (0.00%) 
Injury, poisoning and procedural complications     
Jaw Fracture  1  0/231 (0.00%)  1/99 (1.01%) 
Joint Injury  1  1/231 (0.43%)  0/99 (0.00%) 
Overdose  1  0/231 (0.00%)  1/99 (1.01%) 
Stent Occlusion  1  1/231 (0.43%)  0/99 (0.00%) 
Venomous Bite  1  1/231 (0.43%)  0/99 (0.00%) 
C-Reactive Protein Increased  1  1/231 (0.43%)  0/99 (0.00%) 
Electrocardiogram Qt Prolonged  1  1/231 (0.43%)  0/99 (0.00%) 
International Normalised Ratio Increased  1  1/231 (0.43%)  0/99 (0.00%) 
Prostatic Specific Antigen Increased  1  0/231 (0.00%)  1/99 (1.01%) 
Metabolism and nutrition disorders     
Decreased Appetite  1  4/231 (1.73%)  0/99 (0.00%) 
Hypercalcaemia  1  3/231 (1.30%)  0/99 (0.00%) 
Dehydration  1  2/231 (0.87%)  0/99 (0.00%) 
Hypocalcaemia  1  2/231 (0.87%)  0/99 (0.00%) 
Hypokalaemia  1  2/231 (0.87%)  0/99 (0.00%) 
Diabetes Mellitus  1  0/231 (0.00%)  1/99 (1.01%) 
Hypoglycaemia  1  1/231 (0.43%)  0/99 (0.00%) 
Hyponatraemia  1  1/231 (0.43%)  0/99 (0.00%) 
Malnutrition  1  1/231 (0.43%)  0/99 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal Cell Carcinoma  1  0/231 (0.00%)  1/99 (1.01%) 
Metastases To Bone  1  1/231 (0.43%)  0/99 (0.00%) 
Phaeochromocytoma  1  0/231 (0.00%)  1/99 (1.01%) 
Nervous system disorders     
Loss Of Consciousness  1  2/231 (0.87%)  0/99 (0.00%) 
Transient Ischaemic Attack  1  2/231 (0.87%)  0/99 (0.00%) 
Brain Oedema  1  1/231 (0.43%)  0/99 (0.00%) 
Cerebral Ischaemia  1  1/231 (0.43%)  0/99 (0.00%) 
Depressed Level Of Consciousness  1  1/231 (0.43%)  0/99 (0.00%) 
Hemiparesis  1  0/231 (0.00%)  1/99 (1.01%) 
Neuralgia  1  0/231 (0.00%)  1/99 (1.01%) 
Peripheral Sensorimotor Neuropathy  1  1/231 (0.43%)  0/99 (0.00%) 
Psychiatric disorders     
Depression  1  3/231 (1.30%)  0/99 (0.00%) 
Bipolar Disorder  1  1/231 (0.43%)  0/99 (0.00%) 
Renal and urinary disorders     
Nephrolithiasis  1  2/231 (0.87%)  0/99 (0.00%) 
Anuria  1  1/231 (0.43%)  0/99 (0.00%) 
Calculus Ureteric  1  1/231 (0.43%)  0/99 (0.00%) 
Renal Colic  1  1/231 (0.43%)  0/99 (0.00%) 
Renal Failure  1  1/231 (0.43%)  0/99 (0.00%) 
Tubulointerstitial Nephritis  1  1/231 (0.43%)  0/99 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonitis  1  2/231 (0.87%)  0/99 (0.00%) 
Bronchospasm  1  1/231 (0.43%)  0/99 (0.00%) 
Chylothorax  1  1/231 (0.43%)  0/99 (0.00%) 
Dyspnoea  1  1/231 (0.43%)  0/99 (0.00%) 
Haemoptysis  1  1/231 (0.43%)  1/99 (1.01%) 
Pleural Effusion  1  0/231 (0.00%)  1/99 (1.01%) 
Pneumonia Aspiration  1  1/231 (0.43%)  0/99 (0.00%) 
Pulmonary Thrombosis  1  0/231 (0.00%)  1/99 (1.01%) 
Respiratory Arrest  1  1/231 (0.43%)  0/99 (0.00%) 
Respiratory Failure  1  1/231 (0.43%)  0/99 (0.00%) 
Skin and subcutaneous tissue disorders     
Photosensitivity Reaction  1  2/231 (0.87%)  0/99 (0.00%) 
Pruritus  1  1/231 (0.43%)  0/99 (0.00%) 
Rash  1  1/231 (0.43%)  0/99 (0.00%) 
Skin Ulcer  1  1/231 (0.43%)  0/99 (0.00%) 
Vascular disorders     
Hypertensive Crisis  1  4/231 (1.73%)  0/99 (0.00%) 
Hypertension  1  3/231 (1.30%)  0/99 (0.00%) 
Accelerated Hypertension  1  1/231 (0.43%)  0/99 (0.00%) 
Pelvic Venous Thrombosis  1  1/231 (0.43%)  0/99 (0.00%) 
Vena Cava Thrombosis  1  1/231 (0.43%)  0/99 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vandetanib 300 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   230/231 (99.57%)   90/99 (90.91%) 
Endocrine disorders     
Hypothyroidism  1  15/231 (6.49%)  0/99 (0.00%) 
Eye disorders     
Vision Blurred  1  19/231 (8.23%)  1/99 (1.01%) 
Gastrointestinal disorders     
Diarrhoea  1  128/231 (55.41%)  26/99 (26.26%) 
Nausea  1  77/231 (33.33%)  16/99 (16.16%) 
Vomiting  1  33/231 (14.29%)  7/99 (7.07%) 
Abdominal Pain  1  31/231 (13.42%)  5/99 (5.05%) 
Dyspepsia  1  25/231 (10.82%)  4/99 (4.04%) 
Abdominal Pain Upper  1  20/231 (8.66%)  5/99 (5.05%) 
Dry Mouth  1  20/231 (8.66%)  3/99 (3.03%) 
Constipation  1  13/231 (5.63%)  5/99 (5.05%) 
Toothache  1  7/231 (3.03%)  5/99 (5.05%) 
General disorders     
Fatigue  1  54/231 (23.38%)  22/99 (22.22%) 
Asthenia  1  33/231 (14.29%)  11/99 (11.11%) 
Pyrexia  1  17/231 (7.36%)  3/99 (3.03%) 
Infections and infestations     
Nasopharyngitis  1  26/231 (11.26%)  9/99 (9.09%) 
Upper Respiratory Tract Infection  1  19/231 (8.23%)  3/99 (3.03%) 
Influenza  1  16/231 (6.93%)  3/99 (3.03%) 
Urinary Tract Infection  1  15/231 (6.49%)  6/99 (6.06%) 
Bronchitis  1  10/231 (4.33%)  6/99 (6.06%) 
Electrocardiogram Qt Prolonged  1  32/231 (13.85%)  1/99 (1.01%) 
Weight Decreased  1  24/231 (10.39%)  9/99 (9.09%) 
Metabolism and nutrition disorders     
Decreased Appetite  1  46/231 (19.91%)  12/99 (12.12%) 
Hypocalcaemia  1  23/231 (9.96%)  3/99 (3.03%) 
Musculoskeletal and connective tissue disorders     
Back Pain  1  21/231 (9.09%)  20/99 (20.20%) 
Arthralgia  1  18/231 (7.79%)  10/99 (10.10%) 
Musculoskeletal Chest Pain  1  16/231 (6.93%)  5/99 (5.05%) 
Pain In Extremity  1  16/231 (6.93%)  13/99 (13.13%) 
Muscle Spasms  1  15/231 (6.49%)  1/99 (1.01%) 
Neck Pain  1  14/231 (6.06%)  8/99 (8.08%) 
Musculoskeletal Pain  1  12/231 (5.19%)  9/99 (9.09%) 
Nervous system disorders     
Headache  1  59/231 (25.54%)  9/99 (9.09%) 
Dizziness  1  20/231 (8.66%)  6/99 (6.06%) 
Dysgeusia  1  19/231 (8.23%)  3/99 (3.03%) 
Paraesthesia  1  12/231 (5.19%)  3/99 (3.03%) 
Psychiatric disorders     
Insomnia  1  30/231 (12.99%)  10/99 (10.10%) 
Depression  1  19/231 (8.23%)  3/99 (3.03%) 
Anxiety  1  13/231 (5.63%)  5/99 (5.05%) 
Renal and urinary disorders     
Proteinuria  1  23/231 (9.96%)  2/99 (2.02%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  25/231 (10.82%)  10/99 (10.10%) 
Oropharyngeal Pain  1  19/231 (8.23%)  6/99 (6.06%) 
Dyspnoea  1  18/231 (7.79%)  9/99 (9.09%) 
Epistaxis  1  18/231 (7.79%)  5/99 (5.05%) 
Dysphonia  1  15/231 (6.49%)  3/99 (3.03%) 
Dyspnoea Exertional  1  3/231 (1.30%)  5/99 (5.05%) 
Skin and subcutaneous tissue disorders     
Rash  1  103/231 (44.59%)  11/99 (11.11%) 
Acne  1  46/231 (19.91%)  5/99 (5.05%) 
Dermatitis Acneiform  1  35/231 (15.15%)  2/99 (2.02%) 
Dry Skin  1  35/231 (15.15%)  5/99 (5.05%) 
Photosensitivity Reaction  1  29/231 (12.55%)  0/99 (0.00%) 
Pruritus  1  24/231 (10.39%)  4/99 (4.04%) 
Erythema  1  23/231 (9.96%)  3/99 (3.03%) 
Alopecia  1  18/231 (7.79%)  0/99 (0.00%) 
Vascular disorders     
Hypertension  1  72/231 (31.17%)  5/99 (5.05%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
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.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: Sanofi
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00410761     History of Changes
Other Study ID Numbers: D4200C00058
2005-005077-29 ( EudraCT Number )
LPS14811 ( Other Identifier: Sanofi )
First Submitted: December 6, 2006
First Posted: December 13, 2006
Results First Submitted: April 27, 2011
Results First Posted: March 26, 2012
Last Update Posted: October 11, 2018