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A Study to Assess the Efficacy of Raltegravir (Isentress®), Administered in Combination With Other Antiretroviral Drugs as Treatment for Adults and Older Adults Infected With the Human Immunodeficiency Virus 1 (HIV-1)(MK-0518-145) (Wirksamkeit Von Isentress® Unter Praxisbedingungen) (WIP)

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ClinicalTrials.gov Identifier: NCT01213316
Recruitment Status : Completed
First Posted : October 4, 2010
Results First Posted : May 23, 2016
Last Update Posted : May 23, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition HIV-1 Infection
Intervention Drug: Raltegravir
Enrollment 451
Recruitment Details The Initial Cohort included participants >=18 years old to receive treatment for 96 weeks. With the amendment, participants in the initial cohort >=50 years old could continue for an additional 48-weeks observation (Prolonged Cohort), and participants >=50 years old were newly enrolled to receive treatment for 48 weeks (Amendment Cohort).
Pre-assignment Details  
Arm/Group Title Overall Participants
Hide Arm/Group Description HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
Period Title: Overall Study
Started 451 [1]
Amendment Cohort: Prolonged Participants 48 [2]
Amendment Cohort: Newly Enrolled 179 [3]
Discontinued Treatment Before 48 Weeks 67
Initial Cohort 272 [4]
Completed 451
Not Completed 0
[1]
Participants in the initial and amendment cohorts
[2]
Participants >=50 years of age in the initial cohort who accept an additional 48-week observation
[3]
Participants >=50 years of age newly enrolled
[4]
Participants >=18 years of age in the initial cohort
Arm/Group Title Overall Participants
Hide Arm/Group Description HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
Overall Number of Baseline Participants 451
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 451 participants
50.8  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 451 participants
Female
69
  15.3%
Male
382
  84.7%
1.Primary Outcome
Title Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment
Hide Description The percentage of participants with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 48 weeks of raltegravir treatment was determined.
Time Frame Baseline and 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set included all participants who received at least one dose of raltegravir during the observation period.
Arm/Group Title Overall Participants
Hide Arm/Group Description:
HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
Overall Number of Participants Analyzed 451
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Baseline
50.8
(46.1 to 55.5)
48 weeks
74.7
(70.4 to 78.7)
2.Primary Outcome
Title Percentage of Aging Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment
Hide Description The percentage of aging participants (>=50 years old at initiation of raltegravir treatment) with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 48 weeks of raltegravir treatment was determined.
Time Frame Baseline and 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period.
Arm/Group Title Aging Participants
Hide Arm/Group Description:
HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
Overall Number of Participants Analyzed 227
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Baseline
62.1
(55.5 to 68.4)
48 weeks
77.5
(71.5 to 82.8)
3.Secondary Outcome
Title Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 96 Weeks of Raltegravir Treatment
Hide Description The percentage of participants with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 96 weeks of raltegravir treatment was determined.
Time Frame Baseline and 96 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set included participants in the Initial Cohort who received at least one dose of raltegravir during the observation period.
Arm/Group Title Initial Cohort Participants
Hide Arm/Group Description:
HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks in combination with other antiretroviral drugs under conditions representative of standard clinical practice for HIV-1 patients in Germany.
Overall Number of Participants Analyzed 272
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Baseline
43.8
(37.8 to 49.9)
96 weeks
68.0
(62.1 to 73.5)
4.Secondary Outcome
Title HIV-1 Viral Load After 96 Weeks of Raltegravir Treatment
Hide Description The HIV-1 viral load (log10 copies/mL of HIV-1 RNA) was determined at Baseline and after 96 weeks of raltegravir treatment.
Time Frame Baseline and 96 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set included participants in the Initial Cohort who received at least one dose of raltegravir during the observation period.
Arm/Group Title Initial Cohort Participants
Hide Arm/Group Description:
HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks in combination with other antiretroviral drugs under conditions representative of standard clinical practice for HIV-1 patients in Germany.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: Log10 Copies/mL
Baseline 2.90  (1.65)
96 weeks 1.52  (0.43)
5.Secondary Outcome
Title Change From Baseline in CD4+ T-cell Counts After 96 Weeks of Raltegravir Treatment
Hide Description Mean CD4+ T-cell counts were determined at baseline and after 96 weeks of raltegravir treatment. A positive change from baseline indicates an increase in CD4+ T-cell count.
Time Frame Baseline and 96 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set included participants in the Initial Cohort who received at least one dose of raltegravir during the observation period.
Arm/Group Title Initial Cohort Participants
Hide Arm/Group Description:
HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks in combination with other antiretroviral drugs under conditions representative of standard clinical practice for HIV-1 patients in Germany.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: CD4+ T-cells/µL
Baseline 461.9  (286.35)
Change from Baseline at 96 weeks: n=216 161.7  (225.98)
6.Secondary Outcome
Title HIV-1 Viral Load in Aging Participants After 48 Weeks of Raltegravir Treatment
Hide Description The HIV-1 viral load (log10 copies/mL of HIV-1 RNA) was determined in aging participants (>=50 years old at initiation of raltegravir treatment) at Baseline and after 48 weeks of raltegravir treatment.
Time Frame Baseline and 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period.
Arm/Group Title Aging Participants
Hide Arm/Group Description:
HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
Overall Number of Participants Analyzed 227
Mean (Standard Deviation)
Unit of Measure: Log10 Copies/mL
Baseline 2.28  (1.43)
48 weeks 1.50  (0.45)
7.Secondary Outcome
Title Change From Baseline in CD4+ T-cell Counts in Aging Participants After 48 Weeks of Raltegravir Treatment
Hide Description Mean CD4+ T-cell counts were determined in aging participants (>=50 years old at initiation of raltegravir treatment) at baseline and after 48 weeks of raltegravir treatment was determined. A positive change from baseline indicates an increase in CD4+ T-cell count.
Time Frame Baseline and 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period.
Arm/Group Title Aging Participants
Hide Arm/Group Description:
HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
Overall Number of Participants Analyzed 227
Mean (Standard Deviation)
Unit of Measure: CD4+ T-cells/µL
Baseline 534.4  (297.48)
Change from Baseline at 48 weeks: n=202 63.2  (183.43)
8.Secondary Outcome
Title Change From Baseline in Mean Framingham Risk Score for the 10-Year Cardiovascular Risk in Aging Participants After 48 Weeks of Raltegravir Treatment
Hide Description Mean Framingham Risk for 10-year cardiovascular risk was determined in aging participants (>=50 years old at initiation of raltegravir treatment). Points were allotted for each of following 8 risk factors : sex, age, systolic blood pressure, treatment for hypertension, smoking, diabetes, total cholesterol, and high-density lipoprotein. The sum of the points for each participant was assigned a percent 10-year cardiovascular risk on a lookup table, and could range from 0% to 100%. The mean Framingham Risk for 10-year cardiovascular risk was then calculated for the analysis population. The change from baseline was calculated as Baseline minus Week 48; a positive change indicates reduced risk. This Outcome Measure was added with Amendment 1 and applies only to aging participants.
Time Frame Baseline and 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period and had evaluable results.
Arm/Group Title Aging Participants
Hide Arm/Group Description:
HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
Overall Number of Participants Analyzed 105
Mean (Standard Deviation)
Unit of Measure: Percentage risk
Score at Baseline 24.1  (17.5)
Change from Baseline at 48 weeks: n=65 1.1  (10.9)
9.Secondary Outcome
Title Change From Baseline in Mean D:A:D Risk Score for the 5-Year Cardiovascular Risk in Aging Participants After 48 Weeks of Raltegravir Treatment
Hide Description Mean Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) Risk Score for 5-year cardiovascular risk was determined in aging participants (>=50 years old at initiation of raltegravir treatment) at Baseline and after 48 weeks of raltegravir treatment. The score included the following 8 risk factors: sex, age, systolic blood pressure, family cardiovascular disease history, current smoking, previous cigarette smoker, diabetes, total cholesterol, high-density lipoprotein, currently on indinavir, currently on lopinavir, currently on abacavir, duration and current use of indinavir and duration and current use of lopinavir. The D:A:D Risk Score is interpreted as low: <1%; moderate: 1-5%; high: 5-10%; and very high: >10%. The change from baseline was calculated as Week 48 minus Baseline; a positive change indicates increased risk. This Outcome Measure was added with Amendment 1 and applies only to aging participants.
Time Frame Baseline and 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period and had evaluable results.
Arm/Group Title Aging Participants
Hide Arm/Group Description:
HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
Overall Number of Participants Analyzed 91
Mean (Standard Deviation)
Unit of Measure: Percentage risk
Score at Baseline 9.4  (8.7)
Change from Baseline at 48 weeks: n=57 4.2  (9.5)
10.Secondary Outcome
Title Percentage of Aging Participants With Concomitant Diseases at Baseline
Hide Description The percentage of aging participants with Baseline comorbidities was reported. This Outcome Measure was added with Amendment 1 and applies only to aging participants.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period.
Arm/Group Title Aging Participants
Hide Arm/Group Description:
HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
Overall Number of Participants Analyzed 227
Measure Type: Number
Unit of Measure: Percentage of participants
93.8
11.Secondary Outcome
Title Percentage of Aging Participants Taking Concomitant Medications at Baseline
Hide Description The percentage of aging participants taking concomitant medication in addition to their other antiretroviral therapy was reported. This Outcome Measure was added with Amendment 1 and applies only to aging participants.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period.
Arm/Group Title Aging Participants
Hide Arm/Group Description:
HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
Overall Number of Participants Analyzed 227
Measure Type: Number
Unit of Measure: Percentage of participants
74.9
Time Frame Overall Participants: up to 48 weeks; Initial Cohort Participants: up to 96 weeks; Aging Participants: up to 48 weeks.
Adverse Event Reporting Description Overall Participants and Aging Participants: MedDRA version 17.1; Initial Cohort Participants: MedDRA version 14.1.
 
Arm/Group Title Overall Participants Initial Cohort Participants Aging Participants
Hide Arm/Group Description HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany. HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany. HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
All-Cause Mortality
Overall Participants Initial Cohort Participants Aging Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Overall Participants Initial Cohort Participants Aging Participants
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   34/451 (7.54%)      25/272 (9.19%)      17/227 (7.49%)    
Blood and lymphatic system disorders       
Anaemia megaloblastic  1  1/451 (0.22%)  1 0/272 (0.00%)  0 1/227 (0.44%)  1
Cardiac disorders       
Angina pectoris  1  1/451 (0.22%)  1 1/272 (0.37%)  1 0/227 (0.00%)  0
Arrhythmia  1  1/451 (0.22%)  1 0/272 (0.00%)  0 1/227 (0.44%)  1
Cardiogenic shock  1  1/451 (0.22%)  1 1/272 (0.37%)  1 0/227 (0.00%)  0
Myocardial infarction  1  1/451 (0.22%)  1 1/272 (0.37%)  1 0/227 (0.00%)  0
Sinus tachycardia  1  0/451 (0.00%)  0 1/272 (0.37%)  1 0/227 (0.00%)  0
Gastrointestinal disorders       
Anal fistula  1  1/451 (0.22%)  1 1/272 (0.37%)  1 0/227 (0.00%)  0
Diarrhoea  1  1/451 (0.22%)  1 1/272 (0.37%)  1 0/227 (0.00%)  0
Pancreatitis acute  1  1/451 (0.22%)  1 1/272 (0.37%)  1 0/227 (0.00%)  0
Gastric ulcer haemorrhage  1  1/451 (0.22%)  1 1/272 (0.37%)  1 0/227 (0.00%)  0
General disorders       
Chest pain  1  1/451 (0.22%)  1 0/272 (0.00%)  0 1/227 (0.44%)  1
Asthenia  1  1/451 (0.22%)  2 0/272 (0.00%)  0 1/227 (0.44%)  2
Fatigue  1  1/451 (0.22%)  1 0/272 (0.00%)  0 1/227 (0.44%)  1
Hepatobiliary disorders       
Hepatic failure  1  1/451 (0.22%)  1 1/272 (0.37%)  1 0/227 (0.00%)  0
Cholelithiasis  1  0/451 (0.00%)  0 1/272 (0.37%)  1 0/227 (0.00%)  0
Immune system disorders       
Hypersensitivity  1  1/451 (0.22%)  1 1/272 (0.37%)  1 0/227 (0.00%)  0
Infections and infestations       
Gastroenteritis  1  1/451 (0.22%)  1 0/272 (0.00%)  0 1/227 (0.44%)  1
Pyelonephritis  1  1/451 (0.22%)  1 0/272 (0.00%)  0 1/227 (0.44%)  1
Spirochaetal infection  1  1/451 (0.22%)  1 0/272 (0.00%)  0 1/227 (0.44%)  1
Lung abscess  1  1/451 (0.22%)  1 0/272 (0.00%)  0 1/227 (0.44%)  1
Hepatitis C  1  0/451 (0.00%)  0 1/272 (0.37%)  1 0/227 (0.00%)  0
Syphilis  1  0/451 (0.00%)  0 1/272 (0.37%)  1 0/227 (0.00%)  0
Investigations       
Blood triglycerides increased  1  1/451 (0.22%)  2 0/272 (0.00%)  0 1/227 (0.44%)  2
C-reactive protein increased  1  1/451 (0.22%)  1 0/272 (0.00%)  0 1/227 (0.44%)  1
Electrocardiogram Q wave abnormal  1  1/451 (0.22%)  1 0/272 (0.00%)  0 1/227 (0.44%)  1
Heart rate increased  1  1/451 (0.22%)  1 0/272 (0.00%)  0 1/227 (0.44%)  1
Lipase increased  1  2/451 (0.44%)  2 2/272 (0.74%)  2 2/227 (0.88%)  2
Transaminases increased  1  1/451 (0.22%)  1 1/272 (0.37%)  1 0/227 (0.00%)  0
Weight increased  1  1/451 (0.22%)  1 0/272 (0.00%)  0 1/227 (0.44%)  1
Blood bilirubin increased  1  0/451 (0.00%)  0 1/272 (0.37%)  1 0/227 (0.00%)  0
Metabolism and nutrition disorders       
Decreased appetite  1  1/451 (0.22%)  1 0/272 (0.00%)  0 1/227 (0.44%)  1
Dehydration  1  1/451 (0.22%)  1 1/272 (0.37%)  1 0/227 (0.00%)  0
Hypertriglyceridaemia  1  0/451 (0.00%)  0 1/272 (0.37%)  1 0/227 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Osteoarthritis  1  1/451 (0.22%)  1 0/272 (0.00%)  0 1/227 (0.44%)  1
Osteonecrosis  1  1/451 (0.22%)  1 0/272 (0.00%)  0 1/227 (0.44%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Bladder cancer  1  1/451 (0.22%)  1 1/272 (0.37%)  1 0/227 (0.00%)  0
Diffuse large B-cell lymphoma  1  1/451 (0.22%)  1 0/272 (0.00%)  0 1/227 (0.44%)  1
Glioblastoma  1  1/451 (0.22%)  1 0/272 (0.00%)  0 1/227 (0.44%)  1
Kaposi's sarcoma  1  2/451 (0.44%)  2 1/272 (0.37%)  1 1/227 (0.44%)  1
Non-Hodgkin's lymphoma recurrent  1  1/451 (0.22%)  1 1/272 (0.37%)  1 0/227 (0.00%)  0
Salivary gland cancer  1  1/451 (0.22%)  1 0/272 (0.00%)  0 1/227 (0.44%)  1
Neoplasm malignant  1  1/451 (0.22%)  1 1/272 (0.37%)  1 0/227 (0.00%)  0
Nervous system disorders       
Dizziness  1  3/451 (0.67%)  3 0/272 (0.00%)  0 3/227 (1.32%)  3
Cerebral infarction  1  1/451 (0.22%)  1 1/272 (0.37%)  1 0/227 (0.00%)  0
Psychiatric disorders       
Depressed mood  1  1/451 (0.22%)  1 0/272 (0.00%)  0 1/227 (0.44%)  1
Depression  1  1/451 (0.22%)  1 0/272 (0.00%)  0 1/227 (0.44%)  1
Panic attack  1  1/451 (0.22%)  1 0/272 (0.00%)  0 1/227 (0.44%)  1
Suicide attempt  1  2/451 (0.44%)  2 2/272 (0.74%)  2 0/227 (0.00%)  0
Renal and urinary disorders       
Calculus bladder  1  0/451 (0.00%)  0 1/272 (0.37%)  1 0/227 (0.00%)  0
Nephrolithiasis  1  0/451 (0.00%)  0 1/272 (0.37%)  1 0/227 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  1/451 (0.22%)  1 0/272 (0.00%)  0 1/227 (0.44%)  1
Dyspnoea exertional  1  2/451 (0.44%)  2 0/272 (0.00%)  0 2/227 (0.88%)  2
Respiratory tract haemorrhage  1  1/451 (0.22%)  1 0/272 (0.00%)  0 1/227 (0.44%)  1
Surgical and medical procedures       
Cholecystectomy  1  1/451 (0.22%)  1 1/272 (0.37%)  1 0/227 (0.00%)  0
Vascular disorders       
Hypertension  1  1/451 (0.22%)  1 0/272 (0.00%)  0 1/227 (0.44%)  1
Gastrointestinal haemorrhage  1  0/451 (0.00%)  0 1/272 (0.37%)  1 0/227 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1 and 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Overall Participants Initial Cohort Participants Aging Participants
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/451 (0.00%)      0/272 (0.00%)      0/227 (0.00%)    
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 results of this study will be published by the sponsor according to the current guidelines for publication. The Contract Research Organization will assist the sponsor with initial publication. Further details will be laid down in the financial agreement between the sponsor and the Contract Research Organization.
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: NCT01213316     History of Changes
Other Study ID Numbers: 0518-145
First Submitted: September 30, 2010
First Posted: October 4, 2010
Results First Submitted: March 8, 2016
Results First Posted: May 23, 2016
Last Update Posted: May 23, 2016