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Study the Safety and Effectiveness of MK7009 in Hepatitis C Infected Patients (MK-7009-004)(COMPLETED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00518622
Recruitment Status : Completed
First Posted : August 21, 2007
Results First Posted : September 16, 2009
Last Update Posted : August 25, 2015
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 Hepatitis C
Interventions Drug: Comparator: MK7009
Drug: Comparator: Placebo
Enrollment 40
Recruitment Details

This study was conducted at 11 sites in the US and 1 site in Germany.

Date of first patient visit: 6-Jul-2007; Date of last patient visit: 5-Sep-2008.

Pre-assignment Details To be eligible for enrollment into this study, all patients must have met a number of laboratory criteria including, but not limited to, the presence of hepatitis C virus (HCV) ribonucleic acid (RNA) and HCV genotyping.
Arm/Group Title 25 mg b.i.d. MK7009 75 mg b.i.d. MK7009 250 mg b.i.d. MK7009 500 mg b.i.d. MK7009 700 mg b.i.d. MK7009 125 mg q.d. MK7009 600 mg q.d. MK7009 Placebo
Hide Arm/Group Description Patients received an oral dose of 25mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8. Patients received an oral dose of 75mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8. Patients received an oral dose of 250 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8. Patients received an oral dose of 500 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8. Patients received an oral dose of 700 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.

Patients received an oral dose of 125 mg MK7009 in the morning (once a day (q.d.)) and an oral dose of matching placebo in the evening for 7 days.

Patients received 125 mg of MK7009 on the morning of Day 8.

Patients received an oral dose of 600 mg MK7009 in the morning (q.d.) and an oral dose of matching placebo in the evening for 7 days. Patients received 600 mg of MK7009 on the morning of Day 8. Patients received an oral dose of matching placebo twice a day 9 (b.i.d.) for 7 days and on the morning of Day 8.
Period Title: Overall Study
Started 3 6 6 5 6 5 4 5
Completed Therapy 3 [1] 5 6 5 6 5 4 5
Discontinued Therapy 0 [2] 1 0 0 0 0 0 0
Completed 3 5 5 5 6 5 4 5
Not Completed 0 1 1 0 0 0 0 0
Reason Not Completed
Lost to Follow-up             0             0             1             0             0             0             0             0
Study medication taken incorrectly             0             1             0             0             0             0             0             0
[1]
Completed therapy defined if participant has taken 8 days of study medication per the protocol.
[2]
Discontinued therapy defined if participant has not taken 8 days of medication per the protocol.
Arm/Group Title 25 mg b.i.d. MK7009 75 mg b.i.d. MK7009 250 mg b.i.d. MK7009 500 mg b.i.d. MK7009 700 mg b.i.d. MK7009 125 mg q.d. MK7009 600 mg q.d. MK7009 Placebo Total
Hide Arm/Group Description Patients received an oral dose of 25mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8. Patients received an oral dose of 75mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8. Patients received an oral dose of 250 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8. Patients received an oral dose of 500 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8. Patients received an oral dose of 700 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.

Patients received an oral dose of 125 mg MK7009 in the morning (once a day (q.d.)) and an oral dose of matching placebo in the evening for 7 days.

Patients received 125 mg of MK7009 on the morning of Day 8.

Patients received an oral dose of 600 mg MK7009 in the morning (q.d.) and an oral dose of matching placebo in the evening for 7 days. Patients received 600 mg of MK7009 on the morning of Day 8. Patients received an oral dose of matching placebo twice a day 9 (b.i.d.) for 7 days and on the morning of Day 8. Total of all reporting groups
Overall Number of Baseline Participants 3 6 6 5 6 5 4 5 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 6 participants 6 participants 5 participants 6 participants 5 participants 4 participants 5 participants 40 participants
47.7  (2.5) 46.8  (4.0) 46.3  (7.1) 49.2  (5.6) 42.3  (9.6) 46.4  (6.8) 41.0  (14.4) 46.2  (5.9) 45.7  (7.4)
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants 6 participants 6 participants 5 participants 6 participants 5 participants 4 participants 5 participants 40 participants
48.0
(45 to 50)
47.5
(40 to 51)
47.0
(38 to 54)
48.0
(41 to 55)
41.0
(28 to 53)
50.0
(38 to 52)
45.5
(21 to 52)
46.0
(40 to 54)
48.0
(21 to 55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 6 participants 6 participants 5 participants 6 participants 5 participants 4 participants 5 participants 40 participants
Female
0
   0.0%
0
   0.0%
3
  50.0%
0
   0.0%
1
  16.7%
2
  40.0%
0
   0.0%
1
  20.0%
7
  17.5%
Male
3
 100.0%
6
 100.0%
3
  50.0%
5
 100.0%
5
  83.3%
3
  60.0%
4
 100.0%
4
  80.0%
33
  82.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 6 participants 6 participants 5 participants 6 participants 5 participants 4 participants 5 participants 40 participants
Caucasian 0 2 5 1 3 2 0 1 14
African American 2 3 1 3 1 3 3 3 19
Hispanic American 1 1 0 1 2 0 1 1 7
Genotype  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 6 participants 6 participants 5 participants 6 participants 5 participants 4 participants 5 participants 40 participants
Genotype 1 1 1 0 1 0 1 0 0 4
Genotype 1a 1 5 5 4 5 2 4 4 30
Genotype 1b 1 0 1 0 1 2 0 1 6
Plasma HCV RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 3 participants 6 participants 6 participants 5 participants 6 participants 5 participants 4 participants 5 participants 40 participants
7.0  (0.4) 6.7  (0.2) 6.8  (0.4) 6.6  (0.4) 6.7  (0.4) 6.6  (0.5) 7.1  (0.5) 6.3  (0.9) 6.7  (0.5)
Plasma HCV RNA  
Median (Full Range)
Unit of measure:  Log10 IU/mL
Number Analyzed 3 participants 6 participants 6 participants 5 participants 6 participants 5 participants 4 participants 5 participants 40 participants
7.0
(6.6 to 7.4)
6.7
(6.4 to 7.1)
6.8
(6.3 to 7.3)
6.7
(6.1 to 7.2)
6.7
(6.2 to 7.4)
6.6
(5.9 to 7.1)
6.9
(6.6 to 7.8)
6.6
(4.8 to 6.9)
6.7
(4.8 to 7.8)
1.Primary Outcome
Title Safety and Tolerability of MK7009
Hide Description Number of participants who reported adverse experiences while on study medication as well as for 14 days after completion of study medication
Time Frame 14 days after completion of study therapy
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients are included in the safety analysis.
Arm/Group Title 25 mg b.i.d. MK7009 75 mg b.i.d. MK7009 250 mg b.i.d. MK7009 500 mg b.i.d. MK7009 700 mg b.i.d. MK7009 125 mg q.d. MK7009 600 mg q.d. MK7009 Placebo
Hide Arm/Group Description:
Patients received an oral dose of 25mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
Patients received an oral dose of 75mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
Patients received an oral dose of 250 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
Patients received an oral dose of 500 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
Patients received an oral dose of 700 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.

Patients received an oral dose of 125 mg MK7009 in the morning (once a day (q.d.)) and an oral dose of matching placebo in the evening for 7 days.

Patients received 125 mg of MK7009 on the morning of Day 8.

Patients received an oral dose of 600 mg MK7009 in the morning (q.d.) and an oral dose of matching placebo in the evening for 7 days. Patients received 600 mg of MK7009 on the morning of Day 8.
Patients received an oral dose of matching placebo twice a day 9 (b.i.d.) for 7 days and on the morning of Day 8.
Overall Number of Participants Analyzed 3 6 6 5 6 5 4 5
Measure Type: Number
Unit of Measure: Participants
2 3 6 4 2 5 1 3
2.Primary Outcome
Title Antiviral Activity of MK7009
Hide Description Change from Baseline in Log10 IU/mL hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 8
Time Frame Baseline and Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population (defined as the study participants that completed the study as defined by the protocol). One participant was excluded from the analysis due to incorrect dosing of study medication.
Arm/Group Title 25 mg b.i.d. MK7009 75 mg b.i.d. MK7009 250 mg b.i.d. MK7009 500 mg b.i.d. MK7009 700 mg b.i.d. MK7009 125 mg q.d. MK7009 600 mg q.d. MK7009 Placebo
Hide Arm/Group Description:
Patients received an oral dose of 25mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
Patients received an oral dose of 75mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
Patients received an oral dose of 250 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
Patients received an oral dose of 500 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
Patients received an oral dose of 700 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.

Patients received an oral dose of 125 mg MK7009 in the morning (once a day (q.d.)) and an oral dose of matching placebo in the evening for 7 days.

Patients received 125 mg of MK7009 on the morning of Day 8.

Patients received an oral dose of 600 mg MK7009 in the morning (q.d.) and an oral dose of matching placebo in the evening for 7 days. Patients received 600 mg of MK7009 on the morning of Day 8.
Patients received an oral dose of matching placebo twice a day 9 (b.i.d.) for 7 days and on the morning of Day 8.
Overall Number of Participants Analyzed 3 5 6 5 6 5 4 5
Mean (Standard Deviation)
Unit of Measure: Log10 IU/mL HCV RNA
-1.90  (0.40) -2.54  (0.69) -2.80  (0.96) -3.27  (0.98) -4.62  (0.39) -1.82  (0.61) -2.35  (0.21) 0.11  (0.18)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 25 mg b.i.d. MK7009, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.01
Confidence Interval 95%
-2.87 to -1.14
Estimation Comments Mean (Day 8 - baseline) HCV RNA for MK7009 25 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 75 mg b.i.d. MK7009, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.64
Confidence Interval 95%
-3.49 to -1.80
Estimation Comments Mean (Day 8 - baseline) HCV RNA for MK7009 75 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 250 mg b.i.d. MK7009, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.90
Confidence Interval 95%
-3.90 to -1.90
Estimation Comments Mean (Day 8 - baseline) HCV RNA for MK7009 250 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 500 mg b.i.d. MK7009, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.38
Confidence Interval 95%
-4.59 to -2.17
Estimation Comments Mean (Day 8 - baseline) HCV RNA for MK7009 500 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 700 mg b.i.d. MK7009
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.73
Confidence Interval 95%
-5.15 to -4.31
Estimation Comments Mean (Day 8 - baseline) HCV RNA for MK7009 700 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 125 mg q.d. MK7009, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.93
Confidence Interval 95%
-2.68 to -1.18
Estimation Comments Mean (Day 8 - baseline) HCV RNA for MK7009 125 mg qd minus mean (Day 8 - baseline) HCV RNA for placebo
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 600 mg q.d. MK7009, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.46
Confidence Interval 95%
-2.78 to -2.13
Estimation Comments Mean (Day 8 - baseline) HCV RNA for MK7009 600 mg qd minus mean (Day 8 - baseline) HCV RNA for placebo
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 25 mg b.i.d. MK7009 75 mg b.i.d. MK7009 250 mg b.i.d. MK7009 500 mg b.i.d. MK7009 700 mg b.i.d. MK7009 125 mg q.d. MK7009 600 mg q.d. MK7009 Placebo
Hide Arm/Group Description Patients received an oral dose of 25mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8. Patients received an oral dose of 75mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8. Patients received an oral dose of 250 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8. Patients received an oral dose of 500 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8. Patients received an oral dose of 700 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.

Patients received an oral dose of 125 mg MK7009 in the morning (once a day (q.d.)) and an oral dose of matching placebo in the evening for 7 days.

Patients received 125 mg of MK7009 on the morning of Day 8.

Patients received an oral dose of 600 mg MK7009 in the morning (q.d.) and an oral dose of matching placebo in the evening for 7 days. Patients received 600 mg of MK7009 on the morning of Day 8. Patients received an oral dose of matching placebo twice a day 9 (b.i.d.) for 7 days and on the morning of Day 8.
All-Cause Mortality
25 mg b.i.d. MK7009 75 mg b.i.d. MK7009 250 mg b.i.d. MK7009 500 mg b.i.d. MK7009 700 mg b.i.d. MK7009 125 mg q.d. MK7009 600 mg q.d. MK7009 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
25 mg b.i.d. MK7009 75 mg b.i.d. MK7009 250 mg b.i.d. MK7009 500 mg b.i.d. MK7009 700 mg b.i.d. MK7009 125 mg q.d. MK7009 600 mg q.d. MK7009 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/5 (0.00%)   0/6 (0.00%)   0/5 (0.00%)   0/4 (0.00%)   0/5 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
25 mg b.i.d. MK7009 75 mg b.i.d. MK7009 250 mg b.i.d. MK7009 500 mg b.i.d. MK7009 700 mg b.i.d. MK7009 125 mg q.d. MK7009 600 mg q.d. MK7009 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/3 (66.67%)   3/6 (50.00%)   6/6 (100.00%)   4/5 (80.00%)   2/6 (33.33%)   5/5 (100.00%)   1/4 (25.00%)   3/5 (60.00%) 
Cardiac disorders                 
Bradycardia * 1  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/5 (0.00%) 
Gastrointestinal disorders                 
Abdominal Discomfort * 1  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/5 (0.00%) 
Constipation * 1  1/3 (33.33%)  0/6 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/5 (0.00%) 
Diarrhea * 1  0/3 (0.00%)  0/6 (0.00%)  3/6 (50.00%)  0/5 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  2/5 (40.00%) 
Dyspepsia * 1  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  0/4 (0.00%)  0/5 (0.00%) 
Flatulence * 1  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  0/6 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/5 (0.00%) 
Gastrooesophageal Reflux Disease * 1  0/3 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  1/5 (20.00%) 
Nausea * 1  1/3 (33.33%)  1/6 (16.67%)  1/6 (16.67%)  1/5 (20.00%)  0/6 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  1/5 (20.00%) 
Vomiting * 1  0/3 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  1/5 (20.00%) 
General disorders                 
Axillary Pain * 1  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  1/5 (20.00%) 
Energy Increased * 1  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/5 (0.00%) 
Fatigue * 1  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/5 (0.00%) 
Malaise * 1  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  1/5 (20.00%) 
Pain * 1  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  1/5 (20.00%) 
Vessel Puncture Site Pain * 1  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  0/4 (0.00%)  0/5 (0.00%) 
Investigations                 
Blood Creatinine Increased * 1  1/3 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  0/6 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/5 (0.00%) 
Blood Potassium Decreased * 1  1/3 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/5 (0.00%) 
Blood Pressure Increased * 1  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/5 (0.00%) 
Blood Urea Increased * 1  0/3 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/5 (0.00%) 
Electrocardiogram PQ Interval Prolonged * 1  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  0/6 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/5 (0.00%) 
Musculoskeletal and connective tissue disorders                 
Musculoskeletal Chest Pain * 1  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/5 (0.00%) 
Nervous system disorders                 
Dizziness * 1  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/5 (0.00%) 
Headache * 1  0/3 (0.00%)  1/6 (16.67%)  2/6 (33.33%)  0/5 (0.00%)  2/6 (33.33%)  2/5 (40.00%)  0/4 (0.00%)  0/5 (0.00%) 
Hypoaesthesia * 1  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/5 (0.00%) 
Sinus Headache * 1  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  0/6 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/5 (0.00%) 
Psychiatric disorders                 
Abnormal Dreams * 1  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  1/5 (20.00%) 
Depression * 1  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  0/6 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/5 (0.00%) 
Insomnia * 1  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/5 (20.00%)  0/6 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/5 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Cough * 1  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  1/5 (20.00%) 
Oropharyngeal Pain * 1  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/5 (0.00%) 
Wheezing * 1  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  0/6 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/5 (0.00%) 
Skin and subcutaneous tissue disorders                 
Dry Skin * 1  0/3 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/5 (0.00%) 
Hyperhidrosis * 1  0/3 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/5 (0.00%) 
Vascular disorders                 
Hypertension * 1  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  0/6 (0.00%)  0/5 (0.00%)  1/4 (25.00%)  0/5 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.0
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.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
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Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00518622    
Other Study ID Numbers: 7009-004
2007_517
First Submitted: August 17, 2007
First Posted: August 21, 2007
Results First Submitted: August 10, 2009
Results First Posted: September 16, 2009
Last Update Posted: August 25, 2015