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A Phase 2 Study Of PF-00232798 In HIV Positive Patients

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ClinicalTrials.gov Identifier: NCT00495677
Recruitment Status : Completed
First Posted : July 3, 2007
Results First Posted : October 30, 2013
Last Update Posted : October 30, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition HIV
Intervention Drug: PF-00232798
Enrollment 43

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo PF-00232798 5 mg PF-00232798 20 mg PF-00232798 150 mg PF-00232798 40 mg PF-00232798 300 mg PF-00232798 400 mg
Hide Arm/Group Description Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1. Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1. Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1. Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1. Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2. Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2. Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
Period Title: Stage 1 (25 Days)
Started 2 6 6 6 0 0 0
Completed 2 6 5 6 0 0 0
Not Completed 0 0 1 0 0 0 0
Reason Not Completed
Adverse Event             0             0             1             0             0             0             0
Period Title: Stage 2 (25 Days)
Started 0 0 0 0 8 8 7
Completed 0 0 0 0 8 8 7
Not Completed 0 0 0 0 0 0 0
Arm/Group Title PF-00232798 5 mg PF-00232798 20 mg PF-00232798 40 mg PF-00232798 150 mg PF-00232798 300 mg PF-00232798 400mg Placebo Total
Hide Arm/Group Description Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1. Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1. Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2. Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1. Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2. Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2. Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1. Total of all reporting groups
Overall Number of Baseline Participants 6 6 8 6 8 7 2 43
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 8 participants 6 participants 8 participants 7 participants 2 participants 43 participants
31.5  (8.9) 39.8  (8.5) 36.5  (5.4) 36.2  (9.1) 36.1  (9.6) 32.9  (5) 29  (5.7) 35.2  (7.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 8 participants 6 participants 8 participants 7 participants 2 participants 43 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
6
 100.0%
6
 100.0%
8
 100.0%
6
 100.0%
8
 100.0%
7
 100.0%
2
 100.0%
43
 100.0%
1.Primary Outcome
Title Change From Baseline in Log 10-transformed Human Immunodeficiency Virus (HIV) Viral Load at Day 11
Hide Description Viral load was determined using the Roche COBAS Taqman HIV-1 assay with a lower limit of detection of 40 copies per milliliter (copies/mL). Samples with an initial reading of less than 1,000,000 copies/mL were diluted into range and re-assayed.
Time Frame Baseline, Day 11
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic population included all participants who were randomized, treated and had at least 1 post-dose HIV viral load measurement in the study.
Arm/Group Title PF-00232798 5 mg PF-00232798 20 mg PF-00232798 40 mg PF-00232798 150 mg PF-00232798 300 mg PF-00232798 400 mg Placebo
Hide Arm/Group Description:
Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
Overall Number of Participants Analyzed 6 5 8 6 8 7 2
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
Baseline 4.692  (0.3075) 4.338  (0.4753) 4.306  (0.8241) 4.483  (0.4322) 4.315  (0.6120) 4.715  (0.3153) 4.482  (0.9800)
Change at Day 11 -0.253  (0.3308) -0.687  (0.4260) -0.916  (0.4267) -1.325  (0.3887) -1.546  (0.3028) -1.492  (0.5103) -0.135  (0.0089)
2.Secondary Outcome
Title Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load
Hide Description The time to rebound of viral load was calculated as the time from the last dose to the time of the first occasion at which the viral load was greater than the baseline value. Results are reported for number of participants who rebound within specified days from last dose and who did not rebound up to Day 25.
Time Frame Day 1 up to Day 25
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic population included all participants who were randomized, treated and had at least 1 post-dose HIV viral load measurement in the study.
Arm/Group Title PF-00232798 5 mg PF-00232798 20 mg PF-00232798 40 mg PF-00232798 150 mg PF-00232798 300 mg PF-00232798 400 mg Placebo
Hide Arm/Group Description:
Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
Overall Number of Participants Analyzed 6 5 8 6 8 7 2
Measure Type: Number
Unit of Measure: participants
Rebound within 2 days 1 0 0 0 0 0 1
Rebound within 3 days 1 0 0 0 0 0 0
Rebound within 5 days 3 0 0 0 0 0 0
Rebound within 9 days 0 1 2 1 1 0 0
Rebound within 12 days 0 2 0 0 0 1 0
Rebound within 15 days 0 1 0 1 1 0 0
No Rebound 1 1 6 4 6 6 1
3.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax)
Hide Description [Not Specified]
Time Frame 0 hour (pre-dose) on Day 1 to 9; 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10; Day 12, 13, 15 morning
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic parameter analysis population included all participants who were randomized, treated and had at least 1 of the pharmacokinetic parameters of interest in the study.
Arm/Group Title PF-00232798 5 mg PF-00232798 20 mg PF-00232798 40 mg PF-00232798 150 mg PF-00232798 300 mg PF-00232798 400 mg
Hide Arm/Group Description:
Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
Overall Number of Participants Analyzed 6 5 8 6 8 7
Geometric Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
25.21  (13.964) 185.57  (268.401) 379.27  (239.376) 2675.57  (860.860) 3793.01  (285.845) 4802.57  (2025.429)
4.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax)
Hide Description [Not Specified]
Time Frame 0 hour (pre-dose) on Day 1 to 9; 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10; Day 12, 13, 15 morning
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic parameter analysis population included all participants who were randomized, treated and had at least 1 of the pharmacokinetic parameters of interest in the study.
Arm/Group Title PF-00232798 5 mg PF-00232798 20 mg PF-00232798 40 mg PF-00232798 150 mg PF-00232798 300 mg PF-00232798 400 mg
Hide Arm/Group Description:
Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
Overall Number of Participants Analyzed 6 5 8 6 8 7
Median (Full Range)
Unit of Measure: hours
3.0000
(1.000 to 6.000)
1.0330
(1.000 to 3.000)
4.0000
(1.000 to 4.000)
3.0415
(2.000 to 4.000)
2.0000
(2.000 to 4.000)
2.0000
(1.000 to 3.000)
5.Secondary Outcome
Title Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
Hide Description AUCtau= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time end of dosing interval (24 hours post-dose).
Time Frame 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic parameter analysis population included all participants who were randomized, treated and had at least 1 of the pharmacokinetic parameters of interest in the study.
Arm/Group Title PF-00232798 5 mg PF-00232798 20 mg PF-00232798 40 mg PF-00232798 150 mg PF-00232798 300 mg PF-00232798 400 mg
Hide Arm/Group Description:
Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
Overall Number of Participants Analyzed 6 5 8 6 8 7
Geometric Mean (Standard Deviation)
Unit of Measure: nanogram*hour per milliliter (ng*hr/mL)
265.3  (181.46) 1157.4  (884.12) 2945.1  (1548.47) 17319.1  (7529.14) 28347.9  (5435.54) 41027.3  (20326.95)
6.Other Pre-specified Outcome
Title Number of Participants With Viral Tropism and Resistance
Hide Description Virus tropism was determined using the Monogram PhenoSense Entry assay; standard Trofile tropisim assay was used for Stage 1 and enhanced sensitivity Trofile tropisim assay was used for Stage 2.
Time Frame Screening, pre-dose on Day 1; Day 11, 25
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Results for this outcome was not reported because data was collected in individual participant listings, but not summarized for analyses.
Arm/Group Title PF-00232798 5 mg PF-00232798 20 mg PF-00232798 40 mg PF-00232798 150 mg PF-00232798 300 mg PF-00232798 400 mg Placebo
Hide Arm/Group Description:
Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
Overall Number of Participants Analyzed 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Other Pre-specified Outcome
Title Number of Participants With Chemokine Receptor 5 (CCR5) Delta 32 Genotyping and Immunophenotyping
Hide Description CCR5 Delta 32 genotyping and immunophenotyping was to be done to assess CCR5 Delta 32 status, other CCR5 polymorphisms, enzymes involved in drug metabolism and/or drug transport proteins in order to measure the impact of genetic variation with respect to PF-00232798 in case any unusual patterns of response or an unexplained excess of adverse events occurred.
Time Frame Pre-dose on Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Results for this outcome were not analyzed because there were no unusual patterns of response or an unexplained excess of adverse events that warranted genotyping.
Arm/Group Title PF-00232798 5 mg PF-00232798 20 mg PF-00232798 40 mg PF-00232798 150 mg PF-00232798 300 mg PF-00232798 400 mg Placebo
Hide Arm/Group Description:
Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
Overall Number of Participants Analyzed 0 0 0 0 0 0 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 AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title PF-00232798 5 mg PF-00232798 20 mg PF-00232798 40 mg PF-00232798 150 mg PF-00232798 300 mg PF-00232798 400mg Placebo
Hide Arm/Group Description Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1. Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1. Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2. Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1. Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2. Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2. Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
All-Cause Mortality
PF-00232798 5 mg PF-00232798 20 mg PF-00232798 40 mg PF-00232798 150 mg PF-00232798 300 mg PF-00232798 400mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PF-00232798 5 mg PF-00232798 20 mg PF-00232798 40 mg PF-00232798 150 mg PF-00232798 300 mg PF-00232798 400mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   1/6 (16.67%)   0/8 (0.00%)   0/6 (0.00%)   0/8 (0.00%)   1/7 (14.29%)   0/2 (0.00%) 
Gastrointestinal disorders               
Anal haemorrhage * 1  0/6 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/2 (0.00%) 
Vascular disorders               
Angiopathy * 1  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/2 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PF-00232798 5 mg PF-00232798 20 mg PF-00232798 40 mg PF-00232798 150 mg PF-00232798 300 mg PF-00232798 400mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/6 (33.33%)   6/6 (100.00%)   7/8 (87.50%)   5/6 (83.33%)   6/8 (75.00%)   3/7 (42.86%)   2/2 (100.00%) 
Ear and labyrinth disorders               
Vertigo * 1  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/6 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/2 (0.00%) 
Eye disorders               
Panophthalmitis * 1  0/6 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/2 (50.00%) 
Gastrointestinal disorders               
Abdominal pain upper * 1  0/6 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  2/6 (33.33%)  0/8 (0.00%)  0/7 (0.00%)  0/2 (0.00%) 
Constipation * 1  1/6 (16.67%)  1/6 (16.67%)  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/2 (0.00%) 
Diarrhoea * 1  0/6 (0.00%)  1/6 (16.67%)  1/8 (12.50%)  0/6 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/2 (0.00%) 
Dry mouth * 1  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/2 (0.00%) 
Flatulence * 1  0/6 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  1/7 (14.29%)  0/2 (0.00%) 
Gastric disorder * 1  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/6 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/2 (0.00%) 
Nausea * 1  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/6 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/2 (0.00%) 
Vomiting * 1  0/6 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/2 (0.00%) 
General disorders               
Chest pain * 1  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/2 (0.00%) 
Fatigue * 1  0/6 (0.00%)  1/6 (16.67%)  2/8 (25.00%)  0/6 (0.00%)  4/8 (50.00%)  0/7 (0.00%)  0/2 (0.00%) 
Hunger * 1  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/6 (0.00%)  2/8 (25.00%)  2/7 (28.57%)  0/2 (0.00%) 
Infections and infestations               
Fungal skin infection * 1  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/6 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/2 (0.00%) 
Hordeolum * 1  0/6 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/7 (0.00%)  0/2 (0.00%) 
Lymphangitis * 1  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/2 (0.00%) 
Nasopharyngitis * 1  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  2/6 (33.33%)  0/8 (0.00%)  0/7 (0.00%)  1/2 (50.00%) 
Tinea pedis * 1  0/6 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/2 (50.00%) 
Urinary tract infection * 1  1/6 (16.67%)  0/6 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/2 (0.00%) 
Investigations               
Transaminases abnormal * 1  0/6 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/2 (0.00%) 
Metabolism and nutrition disorders               
Anorexia * 1  0/6 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/2 (0.00%) 
Musculoskeletal and connective tissue disorders               
Flank pain * 1  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/6 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/2 (0.00%) 
Nervous system disorders               
Dizziness * 1  0/6 (0.00%)  2/6 (33.33%)  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/2 (0.00%) 
Headache * 1  0/6 (0.00%)  1/6 (16.67%)  3/8 (37.50%)  2/6 (33.33%)  0/8 (0.00%)  2/7 (28.57%)  1/2 (50.00%) 
Hypersomnia * 1  1/6 (16.67%)  0/6 (0.00%)  0/8 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/7 (0.00%)  1/2 (50.00%) 
Migraine * 1  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/6 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  1/2 (50.00%) 
Psychiatric disorders               
Sleep disorder * 1  0/6 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/2 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Dyspnoea * 1  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/6 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/2 (0.00%) 
Nasal congestion * 1  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/2 (0.00%) 
Skin and subcutaneous tissue disorders               
Rash * 1  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  1/6 (16.67%)  0/8 (0.00%)  0/7 (0.00%)  0/2 (0.00%) 
Vascular disorders               
Hot flush * 1  0/6 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/2 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
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
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00495677     History of Changes
Other Study ID Numbers: A7691009
First Submitted: June 29, 2007
First Posted: July 3, 2007
Results First Submitted: August 26, 2013
Results First Posted: October 30, 2013
Last Update Posted: October 30, 2013