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A Study to Determine the Safety and Efficacy of Once Daily Raltegravir Compared to Twice Daily Raltegravir (MK-0518-071)

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ClinicalTrials.gov Identifier: NCT00745823
Recruitment Status : Terminated (Primary efficacy analysis at Week 48 did not demonstrate non-inferiority of raltegravir 800 mg once daily versus raltegravir 400 mg twice daily)
First Posted : September 3, 2008
Results First Posted : April 25, 2012
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition HIV
Interventions Drug: Comparator: Raltegravir 400 mg b.i.d.
Drug: Experimental: Raltegravir 800 mg q.d.
Drug: TRUVADA™
Enrollment 775
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Raltegravir 800 mg q.d. Raltegravir 400 mg b.i.d.
Hide Arm/Group Description Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
Period Title: Overall Study
Started 386 389
TREATED Week 0 - 96 382 388
Completed 1 3
Not Completed 385 386
Reason Not Completed
Adverse Event             5             3
Lack of Efficacy             20             6
Lost to Follow-up             10             11
Physician Decision             10             5
Pregnancy             0             4
Withdrawal by Subject             14             8
Study Terminated by Sponsor             326             349
Arm/Group Title Raltegravir 800 mg q.d. Raltegravir 400 mg b.i.d. Total
Hide Arm/Group Description Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks Total of all reporting groups
Overall Number of Baseline Participants 386 389 775
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 386 participants 389 participants 775 participants
Between 18 and 64 years 382 382 764
>=64 years 4 7 11
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 386 participants 389 participants 775 participants
Female
68
  17.6%
90
  23.1%
158
  20.4%
Male
318
  82.4%
299
  76.9%
617
  79.6%
1.Primary Outcome
Title Number of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL at 48 Weeks
Hide Description [Not Specified]
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data were analyzed for all participants treated with study drug. Participants who did not complete the study were treated as treatment failures.
Arm/Group Title Raltegravir 800 mg q.d. Raltegravir 400 mg b.i.d.
Hide Arm/Group Description:
Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
Overall Number of Participants Analyzed 382 386
Measure Type: Number
Unit of Measure: Participants
318 343
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Raltegravir 800 mg q.d., Raltegravir 400 mg b.i.d.
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The 800 mg q.d. dosage was considered non-inferior to 400 mg b.i.d. if the lower bound of the 2-sided exact 95% CI for difference in response rate remained above -10%.
Statistical Test of Hypothesis P-Value 0.044
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.7
Confidence Interval (2-Sided) 95%
-10.7 to -0.83
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With One or More Adverse Events at 48 Weeks
Hide Description [Not Specified]
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data were analyzed for all randomized participants who received at least one dose of study drug.
Arm/Group Title Raltegravir 800 mg q.d. Raltegravir 400 mg b.i.d.
Hide Arm/Group Description:
Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
Overall Number of Participants Analyzed 382 388
Measure Type: Number
Unit of Measure: Participants
331 337
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Raltegravir 800 mg q.d., Raltegravir 400 mg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-5.0 to 4.6
Estimation Comments [Not Specified]
3.Primary Outcome
Title Number of Participants Who Discontinued Due to an Adverse Event at 48 Weeks
Hide Description [Not Specified]
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data were analyzed for all randomized participants who received at least one dose of study drug.
Arm/Group Title Raltegravir 800 mg q.d. Raltegravir 400 mg b.i.d.
Hide Arm/Group Description:
Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
Overall Number of Participants Analyzed 382 388
Measure Type: Number
Unit of Measure: Participants
4 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Raltegravir 800 mg q.d., Raltegravir 400 mg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-1.3 to 2.0
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants With HIV Ribonucleic Acid (RNA) <400 Copies/mL at 48 Weeks
Hide Description [Not Specified]
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data were analyzed for all participants treated with study drug. Participants who did not complete the study were treated as treatment failures.
Arm/Group Title Raltegravir 800 mg q.d. Raltegravir 400 mg b.i.d.
Hide Arm/Group Description:
Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
Overall Number of Participants Analyzed 382 386
Measure Type: Number
Unit of Measure: Participants
338 361
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Raltegravir 800 mg q.d., Raltegravir 400 mg b.i.d.
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The 800 mg q.d. dosage was considered non-inferior to 400 mg b.i.d. if the lower bound of the 2-sided exact 95% CI for difference in response rate remained above -10%.
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.1
Confidence Interval (2-Sided) 95%
-9.29 to -1.06
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Mean Change From Baseline to Week 48 in CD4 Cell Count
Hide Description [Not Specified]
Time Frame Baseline and Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data were analyzed for all participants treated with study drug. Baseline values were carried forward for participants who discontinued treatment due to lack of efficacy.
Arm/Group Title Raltegravir 800 mg q.d. Raltegravir 400 mg b.i.d.
Hide Arm/Group Description:
Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
Overall Number of Participants Analyzed 382 386
Mean (95% Confidence Interval)
Unit of Measure: cells/mm^3
209.76
(194.6 to 224.9)
196.20
(181.8 to 210.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Raltegravir 800 mg q.d., Raltegravir 400 mg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 13.56
Confidence Interval (2-Sided) 95%
-7.29 to 34.40
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants With HIV RNA <50 Copies/mL at 96 Weeks
Hide Description As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Week 96 data analysis was not performed.
Arm/Group Title Raltegravir 800 mg q.d. Raltegravir 400 mg b.i.d.
Hide Arm/Group Description:
Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Number of Participants With HIV RNA <400 Copies/mL at 96 Weeks
Hide Description As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Week 96 data analysis was not performed.
Arm/Group Title Raltegravir 800 mg q.d. Raltegravir 400 mg b.i.d.
Hide Arm/Group Description:
Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Mean Change From Baseline to Week 96 in CD4 Cell Count
Hide Description As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.
Time Frame Baseline and Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Week 96 data analysis was not performed.
Arm/Group Title Raltegravir 800 mg q.d. Raltegravir 400 mg b.i.d.
Hide Arm/Group Description:
Raltegravir 800 mg PO q.d. plus placebo to raltegravir PO b.i.d. plus one tablet of TRUVADA™ for 96 weeks
Raltegravir 400 mg b.i.d. administered with TRUVADA™
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Number of Participants With One or More Adverse Events at 96 Weeks
Hide Description As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Raltegravir 800 mg q.d. Raltegravir 400 mg b.i.d.
Hide Arm/Group Description:
Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Number of Participants Who Discontinued Due to an Adverse Event at 96 Weeks
Hide Description As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Raltegravir 800 mg q.d. Raltegravir 400 mg b.i.d.
Hide Arm/Group Description:
Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Overall Study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Raltegravir 800 mg q.d. Raltegravir 400 mg b.i.d.
Hide Arm/Group Description Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
All-Cause Mortality
Raltegravir 800 mg q.d. Raltegravir 400 mg b.i.d.
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Raltegravir 800 mg q.d. Raltegravir 400 mg b.i.d.
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/382 (7.59%)      46/388 (11.86%)    
Blood and lymphatic system disorders     
Anaemia  1  1/382 (0.26%)  1 0/388 (0.00%)  0
Lymphadenitis  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Lymphadenopathy  1  1/382 (0.26%)  1 0/388 (0.00%)  0
Retroperitoneal lymphadenopathy  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Thrombocytopenia  1  1/382 (0.26%)  1 0/388 (0.00%)  0
Cardiac disorders     
Atrial fibrillation  1  1/382 (0.26%)  1 0/388 (0.00%)  0
Pericarditis  1  1/382 (0.26%)  1 0/388 (0.00%)  0
Gastrointestinal disorders     
Anal fistula  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Diarrhoea  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Inguinal hernia  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Proctalgia  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Vomiting  1  0/382 (0.00%)  0 1/388 (0.26%)  1
General disorders     
Chest pain  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Pyrexia  1  0/382 (0.00%)  0 4/388 (1.03%)  4
Hepatobiliary disorders     
Cholecystitis acute  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Cholecystitis chronic  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Cholelithiasis  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Hepatitis  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Immune system disorders     
Immune reconstitution syndrome  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Infections and infestations     
Abscess intestinal  1  1/382 (0.26%)  1 0/388 (0.00%)  0
Abscess jaw  1  1/382 (0.26%)  1 0/388 (0.00%)  0
Anogenital warts  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Appendicitis  1  2/382 (0.52%)  2 1/388 (0.26%)  1
Cytomegalovirus infection  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Diarrhoea infectious  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Eye infection syphilitic  1  1/382 (0.26%)  1 1/388 (0.26%)  1
Gastroenteritis  1  0/382 (0.00%)  0 2/388 (0.52%)  2
Histoplasmosis  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Meningitis aseptic  1  1/382 (0.26%)  1 0/388 (0.00%)  0
Meningitis cryptococcal  1  1/382 (0.26%)  2 0/388 (0.00%)  0
Meningitis viral  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Mycobacterium avium complex infection  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Orchitis  1  1/382 (0.26%)  1 0/388 (0.00%)  0
Perirectal abscess  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Pneumonia  1  1/382 (0.26%)  1 1/388 (0.26%)  1
Pneumonia pneumococcal  1  1/382 (0.26%)  1 0/388 (0.00%)  0
Post procedural pneumonia  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Sepsis  1  0/382 (0.00%)  0 2/388 (0.52%)  2
Shigella infection  1  1/382 (0.26%)  1 1/388 (0.26%)  1
Injury, poisoning and procedural complications     
Forearm fracture  1  1/382 (0.26%)  1 0/388 (0.00%)  0
Meniscus lesion  1  1/382 (0.26%)  1 0/388 (0.00%)  0
Multiple drug overdose  1  1/382 (0.26%)  1 0/388 (0.00%)  0
Muscle injury  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Penis injury  1  1/382 (0.26%)  1 0/388 (0.00%)  0
Tibia fracture  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Wrist fracture  1  1/382 (0.26%)  1 0/388 (0.00%)  0
Metabolism and nutrition disorders     
Obesity  1  1/382 (0.26%)  1 0/388 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Anal cancer stage 0  1  1/382 (0.26%)  1 0/388 (0.00%)  0
Basal cell carcinoma  1  0/382 (0.00%)  0 2/388 (0.52%)  2
Bowen's disease  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Burkitt's lymphoma  1  0/382 (0.00%)  0 2/388 (0.52%)  2
Colon cancer  1  1/382 (0.26%)  1 0/388 (0.00%)  0
Hodgkin's disease  1  0/382 (0.00%)  0 2/388 (0.52%)  2
Kaposi's sarcoma AIDS related  1  3/382 (0.79%)  3 3/388 (0.77%)  3
Leiomyoma  1  1/382 (0.26%)  1 0/388 (0.00%)  0
Lymphoma  1  1/382 (0.26%)  1 0/388 (0.00%)  0
Prostate cancer  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Renal cell carcinoma  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Retroperitoneal neoplasm metastatic  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Skin cancer  1  0/382 (0.00%)  0 1/388 (0.26%)  2
Nervous system disorders     
Cerebral haemorrhage  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Convulsion  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Transient ischaemic attack  1  1/382 (0.26%)  1 0/388 (0.00%)  0
Psychiatric disorders     
Abnormal behaviour  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Panic attack  1  2/382 (0.52%)  2 0/388 (0.00%)  0
Suicidal ideation  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Suicide attempt  1  1/382 (0.26%)  1 4/388 (1.03%)  4
Renal and urinary disorders     
Nephrolithiasis  1  1/382 (0.26%)  1 1/388 (0.26%)  1
Renal colic  1  2/382 (0.52%)  3 0/388 (0.00%)  0
Renal failure acute  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Reproductive system and breast disorders     
Amenorrhoea  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Epididymitis  1  1/382 (0.26%)  1 0/388 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pleural effusion  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Skin and subcutaneous tissue disorders     
Hypoaesthesia facial  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Psoriasis  1  0/382 (0.00%)  0 1/388 (0.26%)  1
Vascular disorders     
Aortic aneurysm  1  1/382 (0.26%)  1 0/388 (0.00%)  0
Deep vein thrombosis  1  0/382 (0.00%)  0 1/388 (0.26%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Raltegravir 800 mg q.d. Raltegravir 400 mg b.i.d.
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   287/382 (75.13%)      282/388 (72.68%)    
Blood and lymphatic system disorders     
Lymphadenopathy  1  22/382 (5.76%)  23 21/388 (5.41%)  23
Gastrointestinal disorders     
Abdominal pain  1  13/382 (3.40%)  14 21/388 (5.41%)  27
Diarrhoea  1  70/382 (18.32%)  81 70/388 (18.04%)  87
Nausea  1  41/382 (10.73%)  47 54/388 (13.92%)  57
Vomiting  1  24/382 (6.28%)  29 25/388 (6.44%)  36
General disorders     
Fatigue  1  25/382 (6.54%)  28 27/388 (6.96%)  30
Pyrexia  1  19/382 (4.97%)  23 26/388 (6.70%)  35
Infections and infestations     
Bronchitis  1  31/382 (8.12%)  32 28/388 (7.22%)  34
Gastroenteritis  1  21/382 (5.50%)  23 14/388 (3.61%)  18
Influenza  1  25/382 (6.54%)  28 36/388 (9.28%)  40
Nasopharyngitis  1  40/382 (10.47%)  51 54/388 (13.92%)  70
Sinusitis  1  16/382 (4.19%)  17 30/388 (7.73%)  36
Upper respiratory tract infection  1  49/382 (12.83%)  64 54/388 (13.92%)  70
Musculoskeletal and connective tissue disorders     
Arthralgia  1  19/382 (4.97%)  22 25/388 (6.44%)  32
Back pain  1  23/382 (6.02%)  28 22/388 (5.67%)  25
Nervous system disorders     
Dizziness  1  36/382 (9.42%)  39 29/388 (7.47%)  35
Headache  1  58/382 (15.18%)  70 62/388 (15.98%)  87
Psychiatric disorders     
Depression  1  22/382 (5.76%)  22 23/388 (5.93%)  25
Insomnia  1  18/382 (4.71%)  18 22/388 (5.67%)  22
Respiratory, thoracic and mediastinal disorders     
Cough  1  38/382 (9.95%)  40 30/388 (7.73%)  41
Oropharyngeal pain  1  15/382 (3.93%)  19 20/388 (5.15%)  23
Skin and subcutaneous tissue disorders     
Rash  1  23/382 (6.02%)  26 23/388 (5.93%)  27
Vascular disorders     
Hypertension  1  11/382 (2.88%)  11 22/388 (5.67%)  22
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
The study was terminated before the 96-week efficacy analysis. Adverse event data were collected for the entire treatment period up to a maximum of Week 108, which defines the Overall Study period.
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.
Twenty-four months after completion of this study or after publication of the multicenter results, an investigator may publish the results for their study site independently. The sponsor must have the opportunity to review all proposed publications or presentations regarding the study 60 days before submission.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Phone: 1- 800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00745823     History of Changes
Other Study ID Numbers: 0518-071
2008_543 ( Other Identifier: Merck Registration Number )
CTRI/2009/091/000145 ( Registry Identifier: CTRI )
First Submitted: September 2, 2008
First Posted: September 3, 2008
Results First Submitted: March 6, 2012
Results First Posted: April 25, 2012
Last Update Posted: March 21, 2017