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A Phase 2B Multicenter, Randomized, Comparative Trial Of UK-453,061 Versus Etravirine In Combination With Darunavir/Ritonavir And A Nucleos(t)Ide Reverse Transcriptase Inhibitor For The Treatment Of Antiretroviral Experienced HIV-1 Infected Subjects With Evidence Of NNRTI Resistant HIV-1

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00823979
First received: January 15, 2009
Last updated: March 24, 2014
Last verified: March 2014
Results First Received: January 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV-1
Interventions: Drug: UK-453,061 Dose 1
Drug: UK-453,061 Dose 2
Drug: Etravirine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lersivirine 750 mg Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Lersivirine 1000 mg Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Etravirine 200 mg Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.

Participant Flow:   Overall Study
    Lersivirine 750 mg     Lersivirine 1000 mg     Etravirine 200 mg  
STARTED     35     35     35  
Treated     31     32     34  
COMPLETED     6     3     11  
NOT COMPLETED     29     32     24  
Lack of Efficacy                 13                 16                 9  
Lost to Follow-up                 2                 1                 0  
Withdrawal by Subject                 2                 3                 2  
Protocol Violation                 1                 1                 0  
Pregnancy                 0                 1                 0  
Adverse Event                 0                 2                 4  
Unspecified                 2                 0                 1  
Randomized but not Treated                 4                 3                 1  
Study Terminated by Sponsor                 5                 5                 7  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-Treat (ITT) population included all randomized participants who received at least 1 dose of study drug.

Reporting Groups
  Description
Lersivirine 750 mg Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Lersivirine 1000 mg Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Etravirine 200 mg Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Total Total of all reporting groups

Baseline Measures
    Lersivirine 750 mg     Lersivirine 1000 mg     Etravirine 200 mg     Total  
Number of Participants  
[units: participants]
  31     32     34     97  
Age  
[units: years]
Mean ± Standard Deviation
  41.1  ± 8.9     40.0  ± 8.7     41.9  ± 9.1     41.0  ± 8.9  
Gender  
[units: participants]
       
Female     15     18     18     51  
Male     16     14     16     46  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 50 Copies/Milliliter (mL) at Week 24   [ Time Frame: Week 24 ]

2.  Secondary:   Percentage of Participants With HIV-1 RNA Levels <50 Copies/mL at Week 48 and 96   [ Time Frame: Weeks 48, 96 ]

3.  Secondary:   Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Week 24, 48 and 96   [ Time Frame: Week 24, 48, 96 ]

4.  Secondary:   Change From Baseline in log10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96   [ Time Frame: Baseline, Week 24, 48, 96 ]

5.  Secondary:   Time-Averaged Difference (TAD) in log10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96   [ Time Frame: Week 24, 48, 96 ]

6.  Secondary:   Percentage of Participants With Response as Determined by the Time to Loss of Virologic Response (TLOVR50) Algorithm at Week 24, 48 and 96   [ Time Frame: Week 24, 48, 96 ]

7.  Secondary:   Change From Baseline in Cluster of Differentiation 4 (CD4+) Absolute Lymphocyte Counts at Week 24, 48 and 96   [ Time Frame: Baseline, Week 24, 48, 96 ]

8.  Secondary:   Change From Baseline in Cluster of Differentiation 4 (CD4+) Percentage Lymphocyte Counts at Week 24, 48, 96   [ Time Frame: Baseline, Week 24, 48, 96 ]

9.  Secondary:   Number of Participants With Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) Resistance-Associated Mutations (RAMs) and/or Phenotypic Susceptibility at Time of Treatment Failure Through Week 48   [ Time Frame: Baseline through Week 48 ]

10.  Secondary:   Number of Participants With Laboratory Test Abnormalities   [ Time Frame: Baseline up to Week 48 or early termination ]

11.  Secondary:   Lersivirine Success Percentage With Reference to Median Minimum Observed Plasma Concentration (Cmin)   [ Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 ]

12.  Secondary:   Population Pharmacokinetics (PK) of Lersivirine   [ Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame No text entered.
Additional 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.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
Lersivirine 750 mg Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Lersivirine 1000 mg Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Etravirine 200 mg Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.

Other Adverse Events
    Lersivirine 750 mg     Lersivirine 1000 mg     Etravirine 200 mg  
Total, other (not including serious) adverse events        
# participants affected / at risk     27/31     25/32     32/34  
Blood and lymphatic system disorders        
Anaemia * 1      
# participants affected / at risk     1/31 (3.23%)     1/32 (3.13%)     0/34 (0.00%)  
Lymphadenopathy * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     2/34 (5.88%)  
Polycythaemia * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     0/34 (0.00%)  
Thrombocytopenia * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Cardiac disorders        
Coronary artery disease * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Palpitations * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Sinus bradycardia * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     0/34 (0.00%)  
Ear and labyrinth disorders        
Ear pain * 1      
# participants affected / at risk     0/31 (0.00%)     2/32 (6.25%)     0/34 (0.00%)  
Hearing impaired * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     0/34 (0.00%)  
Endocrine disorders        
Hypothyroidism * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Eye disorders        
Conjunctival haemorrhage * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Conjunctivitis * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     1/34 (2.94%)  
Conjunctivitis allergic * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     1/34 (2.94%)  
Uveitis * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Visual acuity reduced * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Gastrointestinal disorders        
Abdominal discomfort * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Abdominal distension * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Abdominal pain * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     1/34 (2.94%)  
Abdominal pain upper * 1      
# participants affected / at risk     1/31 (3.23%)     3/32 (9.38%)     3/34 (8.82%)  
Cheilitis * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     1/34 (2.94%)  
Constipation * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     1/34 (2.94%)  
Dental caries * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     1/34 (2.94%)  
Diarrhoea * 1      
# participants affected / at risk     8/31 (25.81%)     7/32 (21.88%)     6/34 (17.65%)  
Dry mouth * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     0/34 (0.00%)  
Dyspepsia * 1      
# participants affected / at risk     1/31 (3.23%)     2/32 (6.25%)     1/34 (2.94%)  
Faeces hard * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     0/34 (0.00%)  
Flatulence * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Gastritis * 1      
# participants affected / at risk     1/31 (3.23%)     1/32 (3.13%)     0/34 (0.00%)  
Gastrooesophageal reflux disease * 1      
# participants affected / at risk     1/31 (3.23%)     1/32 (3.13%)     1/34 (2.94%)  
Glossodynia * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Haematemesis * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Haemorrhoids * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     1/34 (2.94%)  
Mouth ulceration * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Nausea * 1      
# participants affected / at risk     8/31 (25.81%)     14/32 (43.75%)     4/34 (11.76%)  
Oesophagitis * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Oral disorder * 1      
# participants affected / at risk     1/31 (3.23%)     1/32 (3.13%)     0/34 (0.00%)  
Rectal haemorrhage * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     1/34 (2.94%)  
Salivary hypersecretion * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Vomiting * 1      
# participants affected / at risk     6/31 (19.35%)     3/32 (9.38%)     3/34 (8.82%)  
General disorders        
Asthenia * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Fat tissue increased * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Fatigue * 1      
# participants affected / at risk     0/31 (0.00%)     2/32 (6.25%)     0/34 (0.00%)  
Gait disturbance * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     0/34 (0.00%)  
Pain * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Hepatobiliary disorders        
Hepatitis toxic * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Immune system disorders        
Hypersensitivity * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Infections and infestations        
Abscess neck * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     0/34 (0.00%)  
Acarodermatitis * 1      
# participants affected / at risk     1/31 (3.23%)     1/32 (3.13%)     0/34 (0.00%)  
Acute sinusitis * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Asymptomatic bacteriuria * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Body tinea * 1      
# participants affected / at risk     2/31 (6.45%)     1/32 (3.13%)     0/34 (0.00%)  
Bronchitis * 1      
# participants affected / at risk     2/31 (6.45%)     1/32 (3.13%)     1/34 (2.94%)  
Carbuncle * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Cellulitis * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     0/34 (0.00%)  
Cystitis * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     2/34 (5.88%)  
Dermatophytosis * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     0/34 (0.00%)  
Folliculitis * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Furuncle * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     0/34 (0.00%)  
Gastroenteritis * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     2/34 (5.88%)  
Gastroenteritis viral * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Gingivitis * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Hepatitis B * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Herpes simplex * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Herpes zoster * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     5/34 (14.71%)  
Hordeolum * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Influenza * 1      
# participants affected / at risk     4/31 (12.90%)     0/32 (0.00%)     4/34 (11.76%)  
Labyrinthitis * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Lower respiratory tract infection * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     2/34 (5.88%)  
Myringitis * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Nasopharyngitis * 1      
# participants affected / at risk     2/31 (6.45%)     2/32 (6.25%)     0/34 (0.00%)  
Onychomycosis * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     0/34 (0.00%)  
Oral hairy leukoplakia * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     1/34 (2.94%)  
Otitis media * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Papilloma viral infection * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Paronychia * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     0/34 (0.00%)  
Pharyngitis * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Respiratory tract infection * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     1/34 (2.94%)  
Respiratory tract infection viral * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Rhinitis * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     2/34 (5.88%)  
Sinusitis * 1      
# participants affected / at risk     2/31 (6.45%)     2/32 (6.25%)     0/34 (0.00%)  
Tinea cruris * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     0/34 (0.00%)  
Tinea pedis * 1      
# participants affected / at risk     1/31 (3.23%)     1/32 (3.13%)     1/34 (2.94%)  
Tonsillitis * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Tooth abscess * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     2/34 (5.88%)  
Trichomoniasis * 1      
# participants affected / at risk     1/31 (3.23%)     1/32 (3.13%)     0/34 (0.00%)  
Upper respiratory tract infection * 1      
# participants affected / at risk     3/31 (9.68%)     3/32 (9.38%)     5/34 (14.71%)  
Urinary tract infection * 1      
# participants affected / at risk     0/31 (0.00%)     3/32 (9.38%)     3/34 (8.82%)  
Vaginal infection * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Viral upper respiratory tract infection * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Vulvovaginal candidiasis * 1      
# participants affected / at risk     2/31 (6.45%)     0/32 (0.00%)     0/34 (0.00%)  
Injury, poisoning and procedural complications        
Excoriation * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Muscle strain * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     1/34 (2.94%)  
Radiation associated pain * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     0/34 (0.00%)  
Soft tissue injury * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Wrist fracture * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     0/34 (0.00%)  
Investigations        
Blood cholesterol increased * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     1/34 (2.94%)  
Blood creatine phosphokinase increased * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     1/34 (2.94%)  
Blood glucose increased * 1      
# participants affected / at risk     1/31 (3.23%)     1/32 (3.13%)     2/34 (5.88%)  
Blood thyroid stimulating hormone increased * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     0/34 (0.00%)  
Blood triglycerides increased * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Gamma-glutamyltransferase increased * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Hepatic enzyme abnormal * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     0/34 (0.00%)  
Hepatic enzyme increased * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     1/34 (2.94%)  
Low density lipoprotein increased * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Tetrahydrocortisol urine increased * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Urine leukocyte esterase positive * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Metabolism and nutrition disorders        
Dehydration * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Diabetes mellitus * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Dyslipidaemia * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     2/34 (5.88%)  
Glucose tolerance impaired * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Hypertriglyceridaemia * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Hyperuricaemia * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Impaired fasting glucose * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Type 2 diabetes mellitus * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     1/34 (2.94%)  
Vitamin D deficiency * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     1/34 (2.94%)  
Musculoskeletal and connective tissue disorders        
Arthralgia * 1      
# participants affected / at risk     2/31 (6.45%)     1/32 (3.13%)     1/34 (2.94%)  
Back pain * 1      
# participants affected / at risk     2/31 (6.45%)     0/32 (0.00%)     5/34 (14.71%)  
Intervertebral disc degeneration * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     0/34 (0.00%)  
Joint range of motion decreased * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Joint swelling * 1      
# participants affected / at risk     1/31 (3.23%)     1/32 (3.13%)     0/34 (0.00%)  
Monarthritis * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Muscle spasms * 1      
# participants affected / at risk     0/31 (0.00%)     2/32 (6.25%)     0/34 (0.00%)  
Musculoskeletal pain * 1      
# participants affected / at risk     1/31 (3.23%)     1/32 (3.13%)     1/34 (2.94%)  
Myalgia * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     2/34 (5.88%)  
Neck pain * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     0/34 (0.00%)  
Pain in extremity * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     3/34 (8.82%)  
Pain in jaw * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Tendonitis * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     0/34 (0.00%)  
Nervous system disorders        
Aphasia * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Burning sensation * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Convulsion * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Disturbance in attention * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Dizziness * 1      
# participants affected / at risk     2/31 (6.45%)     2/32 (6.25%)     1/34 (2.94%)  
Headache * 1      
# participants affected / at risk     2/31 (6.45%)     2/32 (6.25%)     4/34 (11.76%)  
Hemiparesis * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     0/34 (0.00%)  
Hemiplegia * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Hypersomnia * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     0/34 (0.00%)  
Hypoaesthesia * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Hypogeusia * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Memory impairment * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     0/34 (0.00%)  
Muscle spasticity * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Neuropathy peripheral * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     1/34 (2.94%)  
Paraesthesia * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Somnolence * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
VIIth nerve paralysis * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Vasogenic cerebral oedema * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     0/34 (0.00%)  
Psychiatric disorders        
Anxiety * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Depressed mood * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     0/34 (0.00%)  
Depression * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     3/34 (8.82%)  
Insomnia * 1      
# participants affected / at risk     2/31 (6.45%)     0/32 (0.00%)     1/34 (2.94%)  
Nightmare * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Renal and urinary disorders        
Proteinuria * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     0/34 (0.00%)  
Renal failure acute * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Reproductive system and breast disorders        
Cervical dysplasia * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Menorrhagia * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     0/34 (0.00%)  
Respiratory, thoracic and mediastinal disorders        
Asthma * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Bronchospasm * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Cough * 1      
# participants affected / at risk     2/31 (6.45%)     0/32 (0.00%)     0/34 (0.00%)  
Epistaxis * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     0/34 (0.00%)  
Lung cyst * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Nasal congestion * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Oropharyngeal pain * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Pleural effusion * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Productive cough * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Rhinitis allergic * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Rhinorrhoea * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Sinus congestion * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Upper-airway cough syndrome * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Skin and subcutaneous tissue disorders        
Dermatitis * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     1/34 (2.94%)  
Dermatitis allergic * 1      
# participants affected / at risk     1/31 (3.23%)     1/32 (3.13%)     0/34 (0.00%)  
Dry skin * 1      
# participants affected / at risk     1/31 (3.23%)     1/32 (3.13%)     0/34 (0.00%)  
Dyshidrosis * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Eczema * 1      
# participants affected / at risk     0/31 (0.00%)     2/32 (6.25%)     0/34 (0.00%)  
Ingrowing nail * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     0/34 (0.00%)  
Intertrigo * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     0/34 (0.00%)  
Lipodystrophy acquired * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     0/34 (0.00%)  
Prurigo * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     0/34 (0.00%)  
Pruritus * 1      
# participants affected / at risk     2/31 (6.45%)     2/32 (6.25%)     1/34 (2.94%)  
Psoriasis * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Rash * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     5/34 (14.71%)  
Rash erythematous * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Rash maculo-papular * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Rash papular * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Scar * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Seborrhoeic dermatitis * 1      
# participants affected / at risk     2/31 (6.45%)     1/32 (3.13%)     0/34 (0.00%)  
Skin hypopigmentation * 1      
# participants affected / at risk     0/31 (0.00%)     0/32 (0.00%)     1/34 (2.94%)  
Skin lesion * 1      
# participants affected / at risk     0/31 (0.00%)     2/32 (6.25%)     1/34 (2.94%)  
Vascular disorders        
Arterial spasm * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Hypertension * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Hypertensive crisis * 1      
# participants affected / at risk     0/31 (0.00%)     1/32 (3.13%)     0/34 (0.00%)  
Hypotension * 1      
# participants affected / at risk     1/31 (3.23%)     0/32 (0.00%)     1/34 (2.94%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA v15.1



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The trial was terminated on 12 April, 2012 due to lack of efficacy at the Week 24 analysis. The decision to terminate the trial was not based on any safety concerns.


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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00823979     History of Changes
Other Study ID Numbers: A5271022
Study First Received: January 15, 2009
Results First Received: January 28, 2014
Last Updated: March 24, 2014
Health Authority: United States: Food and Drug Administration