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Trial record 1 of 1 for:    NCT00372775
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Study Tests The Safety And Effectiveness Of SU011248 In Patients With Non-Small Cell Lung Cancer Having Brain Metastases

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ClinicalTrials.gov Identifier: NCT00372775
Recruitment Status : Completed
First Posted : September 7, 2006
Results First Posted : February 24, 2011
Last Update Posted : February 24, 2011
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Small Cell Lung Cancer
Intervention Drug: Sunitinib
Enrollment 66
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sunitinib
Hide Arm/Group Description Sunitinib 37.5 mg oral capsule daily
Period Title: Overall Study
Started 66
Received Treatment 64
Completed 3
Not Completed 63
Reason Not Completed
Adverse Event             8
Death             15
Objective progression or relapse             30
Global deterioration of health status             6
Withdrawal by Subject             1
Other             1
Not Treated             2
Arm/Group Title Sunitinib
Hide Arm/Group Description Sunitinib 37.5 mg oral capsule daily
Overall Number of Baseline Participants 64
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 64 participants
Between 18 and 44 years 4
Between 45 and 64 years 40
>= 65 years 20
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants
Female
25
  39.1%
Male
39
  60.9%
1.Primary Outcome
Title Progression-Free Survival (PFS)
Hide Description Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. Since day of first dose of medication and day criteria for progression were met, were each counted as a full day, 1 day was added to each calculation. PFS calculated as (first event date minus date of first dose of study medication plus 1) divided by 7.02. Used 7.02 days because it equals(=) 365 days per year divided by 52 weeks per year. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).
Time Frame Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to tumor progression or death (up to 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT): all participants enrolled in the study who received at least 1 dose of study medication.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
Sunitinib 37.5 mg oral capsule daily
Overall Number of Participants Analyzed 64
Median (90% Confidence Interval)
Unit of Measure: Weeks
9.4
(7.5 to 13.1)
2.Secondary Outcome
Title Time to Tumor Progression (TTP)
Hide Description Time from start of study treatment to first documentation of objective tumor progression. Tumor progression defined as greater than or equal to 20 percent (≥20%) increase in sum of longest dimensions of target lesions using as reference smallest sum of longest dimensions recorded since treatment started, or unequivocal progression of existing non-target lesions, or appearance of ≥1 new lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST). TTP = (first event date minus date of first dose of study medication plus 1) divided by 7.02.
Time Frame Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to tumor progression (up to 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Sunitinib
Hide Arm/Group Description:
Sunitinib 37.5 mg oral capsule daily
Overall Number of Participants Analyzed 64
Median (95% Confidence Interval)
Unit of Measure: Weeks
15.1
(8.4 to 15.8)
3.Secondary Outcome
Title Time to Neurological Progression (TNP)
Hide Description Time in weeks between first date criteria for focal neurological deficit were met and date of first dose of medication. Criteria for focal neurological deficit included speech or language difficulties, vision changes, loss of coordination or fine motor control, and seizures. Since day of first dose of medication and day criteria for focal neurological deficit were met were each counted as a full day, 1 day was added to each calculation. TNP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7.02.
Time Frame Baseline, Day 28 to focal neurological deficit (up to 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Sunitinib
Hide Arm/Group Description:
Sunitinib 37.5 mg oral capsule daily
Overall Number of Participants Analyzed 64
Median (Full Range)
Unit of Measure: Weeks
8.1
(0.4 to 58.8)
4.Secondary Outcome
Title Number of Participants With Objective Disease Response
Hide Description Objective disease response defined as participants with confirmed complete response (CR) or partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as disappearance of all target lesions. PR defined as ≥30% decrease in sum of longest dimensions of target lesions taking as a reference the baseline sum longest dimensions.
Time Frame Baseline and Day 1 of Week 5, 9, 17, 25, 33, 41, and 49
Hide Outcome Measure Data
Hide Analysis Population Description
ITT with measurable disease at baseline.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
Sunitinib 37.5 mg oral capsule daily
Overall Number of Participants Analyzed 61
Measure Type: Number
Unit of Measure: Participants
1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Objective Response Rate (ORR) (percent)
Estimated Value 1.6
Confidence Interval (2-Sided) 95%
0.0 to 8.8
Estimation Comments Two-Sided Confidence Interval (CI) from Exact Method using the F Distribution
5.Secondary Outcome
Title Time to Objective Intracranial Progression
Hide Description Time in weeks from start of study treatment to first documentation of objective intracranial tumor progression. Intracranial tumor progression defined as ≥25% increase from smallest size in sum of products of all enhancing tumors or appearance of any new tumor, according to World Health Organization (WHO) criteria. Since day of first dose of medication and day criteria for progression were met, were each counted as a full day, 1 day added to each calculation. Time to Objective Intracranial Progression = (first event date minus the date of first dose of study medication plus 1) divided by 7.02.
Time Frame Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to intracranial tumor progression (up to 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Sunitinib
Hide Arm/Group Description:
Sunitinib 37.5 mg oral capsule daily
Overall Number of Participants Analyzed 64
Median (95% Confidence Interval)
Unit of Measure: Weeks
15.4
(12.1 to 24.8)
6.Secondary Outcome
Title Number of Participants With Intracranial Objective Disease Response
Hide Description Intracranial objective disease response defined as participants with confirmed CR or PR, according to WHO criteria. CR defined as disappearance of all enhancing tumor. PR defined as a ≥50% reduction from baseline in sum of the products of all enhancing tumors.
Time Frame Baseline and Day 1 of Week 5, 9, 17, 25, 33, 41, and 49
Hide Outcome Measure Data
Hide Analysis Population Description
ITT with measurable intracranial disease at baseline.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
Sunitinib 37.5 mg oral capsule daily
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: Participants
1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ORR (percent)
Estimated Value 4.3
Confidence Interval (2-Sided) 95%
0.1 to 21.9
Estimation Comments Two-Sided CI from Exact Method using the F Distribution
7.Secondary Outcome
Title Duration of Response (DR)
Hide Description DR defined as difference in weeks between first date criteria for progression occurred, or participant died due to any cause and first date that criteria for a PR or CR were met and subsequently confirmed ≥4 weeks later. Since day criteria for PR or CR were met and first day criteria for progression occurred (or participant died) were each counted as a full day, 1 day was added to each calculation. DR (in weeks) calculated as (first date of PD or death minus first date of CR or PR that was subsequently confirmed plus 1) divided by 7.02.
Time Frame Day 7 of Week 4 and every 4 weeks up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT. DR only calculated for the subgroup of participants with an objective tumor response.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
Sunitinib 37.5 mg oral capsule daily
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Weeks
Overall 32.1
Intracranial 8.26
8.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS calculated as: (date of death minus date of first dose plus 1)divided by 30.4.
Time Frame Baseline until death (up to 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT. In the absence of confirmation of death, survival time was censored to last date of known contact.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
Sunitinib 37.5 mg oral capsule daily
Overall Number of Participants Analyzed 64
Median (95% Confidence Interval)
Unit of Measure: Months
5.8
(3.1 to 8.2)
9.Secondary Outcome
Title Percentage of Participants Surviving at 1 Year
Hide Description Percentage of those surviving at end of 1 year from the first dose of study treatment.
Time Frame Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Sunitinib
Hide Arm/Group Description:
Sunitinib 37.5 mg oral capsule daily
Overall Number of Participants Analyzed 64
Measure Type: Number
Unit of Measure: Percentage of participants
23.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage
Estimated Value 23.4
Confidence Interval (2-Sided) 95%
14.0 to 34.3
Estimation Comments Probability of survival along with the corresponding 2-sided confidence interval for the log [-log(one-year survival rate)] calculated using a normal approximation and then back transformed to give a confidence interval for the one-year survival
10.Secondary Outcome
Title Number of Deaths Due to Intracranial Versus Systemic Progression
Hide Description Number of deaths determined to be intracranial versus systemic progression, according to investigators'assessment.
Time Frame Baseline until death (up to 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Sunitinib
Hide Arm/Group Description:
Sunitinib 37.5 mg oral capsule daily
Overall Number of Participants Analyzed 64
Measure Type: Number
Unit of Measure: Participants
Systemic Progression 48
Intracranial Progression 0
11.Secondary Outcome
Title Change From Baseline in Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network (FACT/NCCN) Lung Symptom Index (FLSI) Score
Hide Description Change from baseline in FLSI Score was calculated Day 1 of Cycle 2 to 13. Each cycle = 28 days. Scores ranged from 0 to 24. Higher scores indicated better outcomes.
Time Frame Baseline, Day 1 of Week 5 and every 4 weeks to end of treatment (up to 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population of participants with post baseline patient-reported outcome data
Arm/Group Title Sunitinib
Hide Arm/Group Description:
Sunitinib 37.5 mg oral capsule daily
Overall Number of Participants Analyzed 45
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
Baseline
17.62
(16.01 to 19.22)
Cycle 2, Day 1
0.52
(-0.89 to 1.92)
Cycle 3, Day 1
1.11
(-0.57 to 2.80)
Cycle 4, Day 1
-0.48
(-2.94 to 1.99)
Cycle 5, Day 1
0.64
(-1.03 to 2.31)
Cycle 6, Day 1
-0.63
(-2.30 to 1.05)
Cycle 7, Day 1
-0.66
(-2.14 to 0.82)
Cycle 8, Day 1
-0.66
(-1.76 to 0.45)
Cycle 9, Day 1
-0.60
(-2.55 to 1.35)
Cycle10, Day 1
-0.12
(-2.47 to 2.23)
Cycle 11, Day 1
-0.20
(-2.96 to 2.56)
Cycle 12, Day 1
-0.40
(-2.99 to 2.19)
Cycle 13, Day 1
-0.80
(-10.96 to 9.36)
12.Secondary Outcome
Title Change From Baseline in FACT/NCCN Brain Symptom Index (FBrSI) Score
Hide Description Change from baseline in FBrSI Score was calculated Day 1 of Cycle 2 to 13. Each cycle = 28 days. Scores ranged from 0 to 60. Higher scores indicated better outcomes.
Time Frame Baseline, Day 1 of Week 5 and every 4 weeks to end of treatment (up to 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population of participants with post baseline patient-reported outcome data
Arm/Group Title Sunitinib
Hide Arm/Group Description:
Sunitinib 37.5 mg oral capsule daily
Overall Number of Participants Analyzed 45
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
Baseline
45.72
(43.52 to 47.92)
Cycle 2, Day 1
-1.25
(-2.84 to 0.34)
Cycle 3, Day 1
-0.58
(-3.52 to 2.37)
Cycle 4, Day 1
0.66
(-2.34 to 3.65)
Cycle 5, Day 1
-1.87
(-5.21 to 1.46)
Cycle 6, Day 1
-1.92
(-5.96 to 2.12)
Cycle 7, Day 1
-2.00
(-5.80 to 1.80)
Cycle 8, Day 1
-0.73
(-4.46 to 2.99)
Cycle 9, Day 1
0.40
(-3.07 to 3.88)
Cycle 10, Day 1
-1.83
(-5.11 to 1.45)
Cycle 11, Day 1
-1.50
(-6.09 to 3.09)
Cycle 12, Day 1
-4.50
(-15.33 to 6.33)
Cycle 13, Day 1
1.21
(-8.77 to 11.20)
13.Secondary Outcome
Title Trough Plasma Concentrations (Ctrough) of Sunitinib
Hide Description A single blood sample (4 milliliters [mL]) collected pre-dose on Day 1 of Cycles 2, 3, and 4 to determine Ctrough of Sunitinib and its metabolite SU12662. Each cycle = 28 days. Ctrough defined as plasma concentration prior to study drug administration. Trough plasma concentrations were dose-corrected.
Time Frame Day 1 of Week 5, 9, and 13
Hide Outcome Measure Data
Hide Analysis Population Description
ITT participants who had pharmacokinetic results for at least 1 day. Ctrough only calculated for subgroup of participants with observations (non-missing concentrations). n = number of participants with evaluable data.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
Sunitinib 37.5 mg oral capsule daily
Overall Number of Participants Analyzed 64
Mean (Standard Deviation)
Unit of Measure: nanograms per milliliter (ng/mL)
Cycle 2, Day 1 (n = 26) 50.89  (20.47)
Cycle 3, Day 1 (n = 21) 46.27  (17.97)
Cycle 4, Day 1 (n = 20) 51.10  (23.13)
14.Secondary Outcome
Title Ctrough of Sunitinib Metabolite (SU012662)
Hide Description A single blood sample (4 mL) collected pre-dose on Day 1 of Cycles 2, 3, and 4 to determine Ctrough of Sunitinib and its metabolite SU12662. Each cycle = 28 days. Ctrough defined as plasma concentration prior to study drug administration. Trough plasma concentrations were dose-corrected.
Time Frame Day 1 of Week 5, 9, and 13
Hide Outcome Measure Data
Hide Analysis Population Description
ITT participants who had pharmacokinetic results for at least 1 day. Ctrough only calculated for subgroup of participants with observations (non-missing concentrations). n = number of participants with evaluable data.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
Sunitinib 37.5 mg oral capsule daily
Overall Number of Participants Analyzed 64
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cycle 2, Day 1 (n = 26) 33.85  (17.64)
Cycle 3, Day 1 (n = 21) 28.45  (15.73)
Cycle 4, Day 1 ( n = 20) 28.91  (18.82)
15.Secondary Outcome
Title Correlation of Polymorphisms in c-Kit, Flt-3 and c-Fms With Blood Counts
Hide Description A blood sample (6mL) collected before treatment with Sunitinib and used to isolate deoxyribonucleic acid (DNA). These samples were not anonymized.
Time Frame Day 1 prior to dosing
Hide Outcome Measure Data
Hide Analysis Population Description
ITT. c-Kit, Flt-3 and c-Fms with blood count samples collected; however, no statistical analyses performed since power was insufficient.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
Sunitinib 37.5 mg oral capsule daily
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile
Hide Description Tumor samples were not anonymized. RNA expression profile was to include colony-stimulating factor 1 receptor (CSF-1R), platelet-derived growth factor receptor alpha and beta (PDGFRalpha and PDGFRbeta), vascular endothelial growth factor (VEGF), VEGF-C, VEGF receptor 1, 2, and 3 (VEGFR1, VEGFR2, and VEGFR3), fibroblast growth factor (FGF), FMS-like tyrosine kinase 3 (FLT3), KIT (stem cell factor receptor), and RET (rearranged during transfection).
Time Frame Day 1 of Week 1 and every 4 weeks up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT. Only 4 RNA samples were collected and no statistical analyses performed.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
Sunitinib 37.5 mg oral capsule daily
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
17.Secondary Outcome
Title PFS in Subgroups Defined by RNA Expression Profiles of Tumors
Hide Description PFS defined as time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was to be determined in subgroups defined by RNA Gene expression (CSF-1R, PDGFRalpha, PDGFRbeta, VEGF, VEGF-C, VEGFR1, VEGFR2, VEGFR3, FGF, FLT3, KIT, and RET) level (low/high relative to expression of Glyceraldehyde-3-Phosphate Dehydrogenase [GAPDH] reference gene). PFS calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7.02.
Time Frame Day 1 of Week 1 and every 4 weeks up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT. Only 4 RNA samples were collected and no statistical analyses performed.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
Sunitinib 37.5 mg oral capsule daily
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Sunitinib
Hide Arm/Group Description Sunitinib 37.5 mg oral capsule daily
All-Cause Mortality
Sunitinib
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Sunitinib
Affected / at Risk (%)
Total   34/64 (53.13%) 
Blood and lymphatic system disorders   
Febrile neutropenia  1  1/64 (1.56%) 
Thrombocytopenia  1  1/64 (1.56%) 
Cardiac disorders   
Cardiac tamponade  1  1/64 (1.56%) 
Pericarditis  1  1/64 (1.56%) 
Gastrointestinal disorders   
Abdominal pain  1  1/64 (1.56%) 
Aphthous stomatitis  1  1/64 (1.56%) 
Constipation  1  1/64 (1.56%) 
Duodenal ulcer  1  1/64 (1.56%) 
Dysphagia  1  1/64 (1.56%) 
Glossodynia  1  1/64 (1.56%) 
Oral pain  1  1/64 (1.56%) 
Vomiting  1  2/64 (3.13%) 
General disorders   
Disease progression  1  13/64 (20.31%) 
General physical health deterioration  1  2/64 (3.13%) 
Pyrexia  1  2/64 (3.13%) 
Hepatobiliary disorders   
Jaundice  1  1/64 (1.56%) 
Infections and infestations   
Infection  1  1/64 (1.56%) 
Lung infection  1  1/64 (1.56%) 
Pyelonephritis  1  1/64 (1.56%) 
Injury, poisoning and procedural complications   
Fracture  1  1/64 (1.56%) 
Investigations   
Pulmonary function test decreased  1  1/64 (1.56%) 
Musculoskeletal and connective tissue disorders   
Bone pain  1  1/64 (1.56%) 
Musculoskeletal chest pain  1  1/64 (1.56%) 
Neck pain  1  1/64 (1.56%) 
Nervous system disorders   
Cerebellar syndrome  1  1/64 (1.56%) 
Cerebral ischaemia  1  1/64 (1.56%) 
Convulsion  1  2/64 (3.13%) 
Epilepsy  1  2/64 (3.13%) 
Tremor  1  1/64 (1.56%) 
Psychiatric disorders   
Intentional self-injury  1  1/64 (1.56%) 
Respiratory, thoracic and mediastinal disorders   
Haemoptysis  1  2/64 (3.13%) 
Oropharyngeal pain  1  1/64 (1.56%) 
Pneumonitis  1  1/64 (1.56%) 
Pulmonary embolism  1  2/64 (3.13%) 
Respiratory failure  1  3/64 (4.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA v12.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sunitinib
Affected / at Risk (%)
Total   63/64 (98.44%) 
Blood and lymphatic system disorders   
Anaemia  1  5/64 (7.81%) 
Neutropenia  1  5/64 (7.81%) 
Thrombocytopenia  1  8/64 (12.50%) 
Gastrointestinal disorders   
Abdominal pain  1  6/64 (9.38%) 
Abdominal pain upper  1  7/64 (10.94%) 
Constipation  1  15/64 (23.44%) 
Diarrhoea  1  12/64 (18.75%) 
Dyspepsia  1  6/64 (9.38%) 
Nausea  1  14/64 (21.88%) 
Stomatitis  1  4/64 (6.25%) 
Vomiting  1  11/64 (17.19%) 
General disorders   
Asthenia  1  11/64 (17.19%) 
Chest pain  1  5/64 (7.81%) 
Fatigue  1  23/64 (35.94%) 
Mucosal inflammation  1  11/64 (17.19%) 
Pain  1  5/64 (7.81%) 
Investigations   
Platelet count decreased  1  4/64 (6.25%) 
Metabolism and nutrition disorders   
Decreased appetite  1  16/64 (25.00%) 
Hypokalaemia  1  6/64 (9.38%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  8/64 (12.50%) 
Bone pain  1  5/64 (7.81%) 
Nervous system disorders   
Dysgeusia  1  4/64 (6.25%) 
Headache  1  5/64 (7.81%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  15/64 (23.44%) 
Dyspnoea  1  13/64 (20.31%) 
Skin and subcutaneous tissue disorders   
Dry skin  1  5/64 (7.81%) 
Rash  1  5/64 (7.81%) 
Vascular disorders   
Hypertension  1  12/64 (18.75%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA v12.1
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00372775    
Other Study ID Numbers: A6181092
First Submitted: September 5, 2006
First Posted: September 7, 2006
Results First Submitted: December 8, 2010
Results First Posted: February 24, 2011
Last Update Posted: February 24, 2011