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Trial record 1 of 1 for:    D4200C00044
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ZD6474 (ZACTIMA™) Phase III Study in EGFR Failures

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ClinicalTrials.gov Identifier: NCT00404924
Recruitment Status : Completed
First Posted : November 29, 2006
Results First Posted : March 26, 2012
Last Update Posted : September 30, 2016
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 Non-Small-Cell Lung Carcinoma
Interventions Drug: ZD6474 (vandetanib)
Other: Best Supportive Care
Enrollment 1140
Recruitment Details First patient enrolled 08 November 2006, last patient enrolled 09 October 2008, cut off date 19 October 2009. 1168 patients were enrolled in the study.
Pre-assignment Details  
Arm/Group Title Vandetanib 300 mg Placebo
Hide Arm/Group Description vandetanib (300 mg daily) plus best supportive care Placebo plus best supportive care
Period Title: Overall Study
Started 617 [1] 307 [1]
Completed 14 [2] 1 [2]
Not Completed 603 306
Reason Not Completed
Adverse Event             75             16
Condition under investigation worsened             475             264
Lost to Follow-up             1             1
Withdrawal by Subject             26             13
Not Specified             25             11
Randomised but not received treatment             1             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) plus best supportive care Placebo plus best supportive care Total of all reporting groups
Overall Number of Baseline Participants 617 307 924
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 617 participants 307 participants 924 participants
59.8
(20 to 85)
60.6
(21 to 84)
60
(20 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 617 participants 307 participants 924 participants
Female
329
  53.3%
160
  52.1%
489
  52.9%
Male
288
  46.7%
147
  47.9%
435
  47.1%
1.Primary Outcome
Title Overall Survival (OS)
Hide Description Overall Survival (OS) is defined as the time from date of randomization until death. Any blinded/unknown patient which have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie, their status must be known at the censored date and should not be lost to follow up or unknown).
Time Frame Time to death in months
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) plus best supportive care
Placebo plus best supportive care
Overall Number of Participants Analyzed 617 307
Median (95% Confidence Interval)
Unit of Measure: Months
8.5
(7.81 to 9.76)
7.8
(6.08 to 9.17)
2.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description Median time (in 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
Time Frame RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression
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) plus best supportive care
Placebo plus best supportive care
Overall Number of Participants Analyzed 617 307
Median (95% Confidence Interval)
Unit of Measure: month
1.9
(1.84 to 2.23)
1.8
(1.74 to 1.84)
3.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)>= 8 weeks, progressive disease (PD) or NE.

Time Frame Each patient was assessed for objective response from the sequence of RECIST scan data up to data cut off. RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression.
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) plus best supportive care
Placebo plus best supportive care
Overall Number of Participants Analyzed 617 307
Measure Type: Number
Unit of Measure: Participants
16 2
4.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) >= 8 weeks
Time Frame RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression
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) plus best supportive care
Placebo plus best supportive care
Overall Number of Participants Analyzed 617 307
Measure Type: Number
Unit of Measure: Participants
189 48
5.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)
Time Frame RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression
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) plus best supportive care
Placebo plus best supportive care
Overall Number of Participants Analyzed 16 2
Median (95% Confidence Interval)
Unit of Measure: Weeks
23.9
(16.57 to 27.00)
24.3
(16.00 to 32.57)
6.Secondary Outcome
Title Time to Deterioration of Disease-related Symptoms (TDS) by Questionnaire - the Lung Cancer Subscale (LCS) a Selection of the FACT-L Focusing on Symptoms of Lung Cancer Plus Pain and Fatigue (LCS-PF)
Hide Description Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of ‘worsened’ with no visit assessment of ‘improved’ within the next 28 days. Where assessment is by a selection of questions from the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire.
Time Frame Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication) and every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit
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) plus best supportive care
Placebo plus best supportive care
Overall Number of Participants Analyzed 617 307
Median (Inter-Quartile Range)
Unit of Measure: weeks
6.1
(5.14 to 8.14)
7.1
(5.86 to 8.43)
Time Frame [Not Specified]
Adverse Event Reporting Description The Safety Analysis Set included 922 patients (619 vandetanib & 303 placebo), which represents more than 99% of all randomized pts. 2 (1 in each arm) were excluded from the SAS as they were not dosed. Additionally 3 pts randomized to receive placebo received at least one dose of vandetanib, these 3 pts are included in the vandetanib arm in the SAS
 
Arm/Group Title Vandetanib Placebo
Hide Arm/Group Description Vandetanib 300 mg Placebo
All-Cause Mortality
Vandetanib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vandetanib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   160/619 (25.85%)   63/303 (20.79%) 
Blood and lymphatic system disorders     
Febrile Neutropenia  1  3/619 (0.48%)  0/303 (0.00%) 
Anaemia  1  0/619 (0.00%)  2/303 (0.66%) 
Thrombocytopenia  1  2/619 (0.32%)  2/303 (0.66%) 
Leukopenia  1  0/619 (0.00%)  1/303 (0.33%) 
Neutropenia  1  1/619 (0.16%)  1/303 (0.33%) 
Cardiac disorders     
Atrial Fibrillation  1  2/619 (0.32%)  0/303 (0.00%) 
Cardiac Failure  1  2/619 (0.32%)  0/303 (0.00%) 
Myocardial Infarction  1  2/619 (0.32%)  1/303 (0.33%) 
Angina Pectoris  1  0/619 (0.00%)  1/303 (0.33%) 
Arrhythmia  1  1/619 (0.16%)  0/303 (0.00%) 
Cardiac Arrest  1  1/619 (0.16%)  0/303 (0.00%) 
Cardiac Valve Disease  1  1/619 (0.16%)  0/303 (0.00%) 
Pericardial Effusion  1  0/619 (0.00%)  1/303 (0.33%) 
Ear and labyrinth disorders     
Deafness  1  1/619 (0.16%)  0/303 (0.00%) 
Vertigo  1  0/619 (0.00%)  1/303 (0.33%) 
Endocrine disorders     
Hyperthyroidism  1  1/619 (0.16%)  0/303 (0.00%) 
Eye disorders     
Diplopia  1  1/619 (0.16%)  0/303 (0.00%) 
Vision Blurred  1  1/619 (0.16%)  0/303 (0.00%) 
Visual Acuity Reduced  1  1/619 (0.16%)  0/303 (0.00%) 
Gastrointestinal disorders     
Diarrhoea  1  8/619 (1.29%)  0/303 (0.00%) 
Vomiting  1  4/619 (0.65%)  3/303 (0.99%) 
Nausea  1  2/619 (0.32%)  1/303 (0.33%) 
Abdominal Distension  1  1/619 (0.16%)  0/303 (0.00%) 
Abdominal Pain  1  1/619 (0.16%)  0/303 (0.00%) 
Ascites  1  0/619 (0.00%)  1/303 (0.33%) 
Constipation  1  1/619 (0.16%)  0/303 (0.00%) 
Duodenal Ulcer  1  1/619 (0.16%)  0/303 (0.00%) 
Enteritis  1  1/619 (0.16%)  0/303 (0.00%) 
Gastrointestinal Perforation  1  0/619 (0.00%)  1/303 (0.33%) 
Gastrooesophageal Reflux Disease  1  1/619 (0.16%)  0/303 (0.00%) 
Gingival Pain  1  1/619 (0.16%)  0/303 (0.00%) 
Ileus Paralytic  1  1/619 (0.16%)  0/303 (0.00%) 
Intestinal Haemorrhage  1  0/619 (0.00%)  1/303 (0.33%) 
Intestinal Perforation  1  0/619 (0.00%)  1/303 (0.33%) 
Neutropenic Colitis  1  1/619 (0.16%)  0/303 (0.00%) 
Pancreatitis  1  1/619 (0.16%)  0/303 (0.00%) 
Paraesthesia Oral  1  0/619 (0.00%)  1/303 (0.33%) 
Pneumatosis Intestinalis  1  1/619 (0.16%)  0/303 (0.00%) 
Proctalgia  1  1/619 (0.16%)  0/303 (0.00%) 
Subileus  1  0/619 (0.00%)  1/303 (0.33%) 
General disorders     
Asthenia  1  5/619 (0.81%)  1/303 (0.33%) 
Death  1  3/619 (0.48%)  0/303 (0.00%) 
Fatigue  1  3/619 (0.48%)  1/303 (0.33%) 
Pyrexia  1  3/619 (0.48%)  3/303 (0.99%) 
Chest Pain  1  1/619 (0.16%)  0/303 (0.00%) 
General Physical Health Deterioration  1  1/619 (0.16%)  0/303 (0.00%) 
Malaise  1  0/619 (0.00%)  1/303 (0.33%) 
Pain  1  1/619 (0.16%)  0/303 (0.00%) 
Hepatobiliary disorders     
Bile Duct Stenosis  1  0/619 (0.00%)  1/303 (0.33%) 
Cytolytic Hepatitis  1  1/619 (0.16%)  0/303 (0.00%) 
Immune system disorders     
Drug Hypersensitivity  1  2/619 (0.32%)  0/303 (0.00%) 
Anaphylactic Reaction  1  1/619 (0.16%)  0/303 (0.00%) 
Infections and infestations     
Pneumonia  1  21/619 (3.39%)  6/303 (1.98%) 
Sepsis  1  3/619 (0.48%)  1/303 (0.33%) 
Lung Infection  1  2/619 (0.32%)  1/303 (0.33%) 
Urinary Tract Infection  1  2/619 (0.32%)  1/303 (0.33%) 
Arthritis Bacterial  1  0/619 (0.00%)  1/303 (0.33%) 
Bacterial Sepsis  1  0/619 (0.00%)  1/303 (0.33%) 
Bronchitis  1  0/619 (0.00%)  1/303 (0.33%) 
Catheter Site Infection  1  1/619 (0.16%)  1/303 (0.33%) 
Cellulitis  1  1/619 (0.16%)  0/303 (0.00%) 
Clostridial Infection  1  1/619 (0.16%)  0/303 (0.00%) 
Empyema  1  0/619 (0.00%)  1/303 (0.33%) 
Gastroenteritis  1  1/619 (0.16%)  0/303 (0.00%) 
Injection Site Abscess  1  1/619 (0.16%)  0/303 (0.00%) 
Lobar Pneumonia  1  1/619 (0.16%)  0/303 (0.00%) 
Lower Respiratory Tract Infection  1  1/619 (0.16%)  1/303 (0.33%) 
Pharyngitis  1  1/619 (0.16%)  0/303 (0.00%) 
Staphylococcal Sepsis  1  1/619 (0.16%)  0/303 (0.00%) 
Subcutaneous Abscess  1  1/619 (0.16%)  0/303 (0.00%) 
Tracheitis  1  1/619 (0.16%)  0/303 (0.00%) 
Upper Respiratory Tract Infection  1  1/619 (0.16%)  1/303 (0.33%) 
Urosepsis  1  1/619 (0.16%)  0/303 (0.00%) 
Injury, poisoning and procedural complications     
Femur Fracture  1  2/619 (0.32%)  0/303 (0.00%) 
Femoral Neck Fracture  1  1/619 (0.16%)  0/303 (0.00%) 
Joint Dislocation  1  1/619 (0.16%)  0/303 (0.00%) 
Multiple Injuries  1  1/619 (0.16%)  0/303 (0.00%) 
Pneumothorax Traumatic  1  1/619 (0.16%)  0/303 (0.00%) 
Wound  1  1/619 (0.16%)  0/303 (0.00%) 
Wrist Fracture  1  1/619 (0.16%)  0/303 (0.00%) 
Electrocardiogram T Wave Inversion  1  1/619 (0.16%)  0/303 (0.00%) 
Lipase Increased  1  1/619 (0.16%)  0/303 (0.00%) 
Neutrophil Count Decreased  1  1/619 (0.16%)  0/303 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  4/619 (0.65%)  1/303 (0.33%) 
Decreased Appetite  1  2/619 (0.32%)  1/303 (0.33%) 
Hyperglycaemia  1  2/619 (0.32%)  0/303 (0.00%) 
Hyponatraemia  1  2/619 (0.32%)  0/303 (0.00%) 
Hypercalcaemia  1  0/619 (0.00%)  1/303 (0.33%) 
Hypoglycaemia  1  1/619 (0.16%)  0/303 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back Pain  1  2/619 (0.32%)  0/303 (0.00%) 
Musculoskeletal Pain  1  2/619 (0.32%)  2/303 (0.66%) 
Arthralgia  1  1/619 (0.16%)  0/303 (0.00%) 
Bone Pain  1  1/619 (0.16%)  0/303 (0.00%) 
Muscle Twitching  1  1/619 (0.16%)  1/303 (0.33%) 
Musculoskeletal Chest Pain  1  1/619 (0.16%)  0/303 (0.00%) 
Myalgia  1  1/619 (0.16%)  0/303 (0.00%) 
Neck Pain  1  1/619 (0.16%)  0/303 (0.00%) 
Osteoarthritis  1  0/619 (0.00%)  1/303 (0.33%) 
Pain In Extremity  1  1/619 (0.16%)  1/303 (0.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer Pain  1  1/619 (0.16%)  0/303 (0.00%) 
Nervous system disorders     
Convulsion  1  5/619 (0.81%)  1/303 (0.33%) 
Cerebral Infarction  1  0/619 (0.00%)  3/303 (0.99%) 
Cerebral Ischaemia  1  3/619 (0.48%)  0/303 (0.00%) 
Cerebrovascular Accident  1  3/619 (0.48%)  1/303 (0.33%) 
Cerebral Haemorrhage  1  1/619 (0.16%)  0/303 (0.00%) 
Cognitive Disorder  1  1/619 (0.16%)  0/303 (0.00%) 
Dizziness  1  1/619 (0.16%)  0/303 (0.00%) 
Encephalitis  1  1/619 (0.16%)  0/303 (0.00%) 
Loss Of Consciousness  1  0/619 (0.00%)  1/303 (0.33%) 
Paraesthesia  1  1/619 (0.16%)  0/303 (0.00%) 
Partial Seizures  1  1/619 (0.16%)  0/303 (0.00%) 
Somnolence  1  1/619 (0.16%)  0/303 (0.00%) 
Subarachnoid Haemorrhage  1  1/619 (0.16%)  0/303 (0.00%) 
Syncope  1  0/619 (0.00%)  1/303 (0.33%) 
Transient Ischaemic Attack  1  1/619 (0.16%)  0/303 (0.00%) 
Tremor  1  1/619 (0.16%)  0/303 (0.00%) 
Psychiatric disorders     
Confusional State  1  0/619 (0.00%)  2/303 (0.66%) 
Anxiety  1  1/619 (0.16%)  0/303 (0.00%) 
Depression  1  1/619 (0.16%)  0/303 (0.00%) 
Renal and urinary disorders     
Urinary Retention  1  0/619 (0.00%)  2/303 (0.66%) 
Calculus Urinary  1  0/619 (0.00%)  1/303 (0.33%) 
Renal Failure  1  1/619 (0.16%)  0/303 (0.00%) 
Renal Failure Acute  1  1/619 (0.16%)  0/303 (0.00%) 
Urinary Incontinence  1  1/619 (0.16%)  0/303 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  12/619 (1.94%)  5/303 (1.65%) 
Pleural Effusion  1  5/619 (0.81%)  5/303 (1.65%) 
Pulmonary Embolism  1  3/619 (0.48%)  5/303 (1.65%) 
Haemoptysis  1  3/619 (0.48%)  0/303 (0.00%) 
Cough  1  2/619 (0.32%)  1/303 (0.33%) 
Pneumonia Aspiration  1  2/619 (0.32%)  0/303 (0.00%) 
Pneumonitis  1  2/619 (0.32%)  0/303 (0.00%) 
Acute Respiratory Distress Syndrome  1  1/619 (0.16%)  0/303 (0.00%) 
Bronchial Haemorrhage  1  1/619 (0.16%)  0/303 (0.00%) 
Bronchospasm  1  1/619 (0.16%)  0/303 (0.00%) 
Idiopathic Pulmonary Fibrosis  1  1/619 (0.16%)  0/303 (0.00%) 
Pneumothorax  1  1/619 (0.16%)  0/303 (0.00%) 
Pulmonary Artery Thrombosis  1  1/619 (0.16%)  0/303 (0.00%) 
Pulmonary Haemorrhage  1  1/619 (0.16%)  1/303 (0.33%) 
Respiratory Failure  1  1/619 (0.16%)  1/303 (0.33%) 
Respiratory Tract Haemorrhage  1  1/619 (0.16%)  0/303 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash  1  4/619 (0.65%)  0/303 (0.00%) 
Stevens-Johnson Syndrome  1  3/619 (0.48%)  0/303 (0.00%) 
Photosensitivity Reaction  1  2/619 (0.32%)  0/303 (0.00%) 
Dermatitis Allergic  1  1/619 (0.16%)  0/303 (0.00%) 
Dry Skin  1  1/619 (0.16%)  0/303 (0.00%) 
Erythema  1  1/619 (0.16%)  0/303 (0.00%) 
Erythema Multiforme  1  1/619 (0.16%)  0/303 (0.00%) 
Rash Pruritic  1  1/619 (0.16%)  0/303 (0.00%) 
Vascular disorders     
Hypertension  1  7/619 (1.13%)  0/303 (0.00%) 
Deep Vein Thrombosis  1  2/619 (0.32%)  0/303 (0.00%) 
Arterial Thrombosis Limb  1  1/619 (0.16%)  0/303 (0.00%) 
Hypotension  1  0/619 (0.00%)  1/303 (0.33%) 
Jugular Vein Thrombosis  1  0/619 (0.00%)  1/303 (0.33%) 
Thrombophlebitis Superficial  1  1/619 (0.16%)  0/303 (0.00%) 
Visceral Arterial Ischaemia  1  0/619 (0.00%)  1/303 (0.33%) 
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 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   557/619 (89.98%)   234/303 (77.23%) 
Blood and lymphatic system disorders     
Anaemia  1  19/619 (3.07%)  19/303 (6.27%) 
Gastrointestinal disorders     
Diarrhoea  1  284/619 (45.88%)  34/303 (11.22%) 
Nausea  1  138/619 (22.29%)  51/303 (16.83%) 
Constipation  1  88/619 (14.22%)  63/303 (20.79%) 
Vomiting  1  82/619 (13.25%)  36/303 (11.88%) 
Stomatitis  1  34/619 (5.49%)  13/303 (4.29%) 
Abdominal Pain  1  26/619 (4.20%)  19/303 (6.27%) 
General disorders     
Fatigue  1  109/619 (17.61%)  50/303 (16.50%) 
Asthenia  1  62/619 (10.02%)  30/303 (9.90%) 
Pyrexia  1  44/619 (7.11%)  29/303 (9.57%) 
Oedema Peripheral  1  33/619 (5.33%)  29/303 (9.57%) 
Weight Decreased  1  47/619 (7.59%)  18/303 (5.94%) 
Electrocardiogram Qt Prolonged  1  37/619 (5.98%)  1/303 (0.33%) 
Metabolism and nutrition disorders     
Decreased Appetite  1  143/619 (23.10%)  63/303 (20.79%) 
Musculoskeletal and connective tissue disorders     
Back Pain  1  54/619 (8.72%)  19/303 (6.27%) 
Musculoskeletal Pain  1  22/619 (3.55%)  20/303 (6.60%) 
Nervous system disorders     
Dizziness  1  68/619 (10.99%)  27/303 (8.91%) 
Headache  1  61/619 (9.85%)  24/303 (7.92%) 
Psychiatric disorders     
Insomnia  1  63/619 (10.18%)  24/303 (7.92%) 
Renal and urinary disorders     
Proteinuria  1  56/619 (9.05%)  10/303 (3.30%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  108/619 (17.45%)  53/303 (17.49%) 
Dyspnoea  1  98/619 (15.83%)  52/303 (17.16%) 
Skin and subcutaneous tissue disorders     
Rash  1  258/619 (41.68%)  33/303 (10.89%) 
Pruritus  1  70/619 (11.31%)  16/303 (5.28%) 
Dry Skin  1  49/619 (7.92%)  8/303 (2.64%) 
Vascular disorders     
Hypertension  1  160/619 (25.85%)  9/303 (2.97%) 
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
Name/Title: Trial Transparency Team
Organization: Sanofi
Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00404924     History of Changes
Other Study ID Numbers: D4200C00044
EUDRACT Number 2006-002384-12
First Submitted: November 28, 2006
First Posted: November 29, 2006
Results First Submitted: April 27, 2011
Results First Posted: March 26, 2012
Last Update Posted: September 30, 2016