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Efficacy and Safety of MK-7622 as Adjunct Therapy in Participants With Alzheimer's Disease (MK-7622-012)

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: NCT01852110
Recruitment Status : Terminated (Stage 1 interim analysis of efficacy met the criteria for early trial termination (futility). The trial was terminated at Stage 1; did not proceed to Stage 2.)
First Posted : May 13, 2013
Results First Posted : February 7, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Alzheimer's Disease
Interventions Drug: MK-7622
Drug: Placebo
Drug: AChEI
Enrollment 240
Recruitment Details Number of Participants Screened: 505 Number of Participants Randomized: 240
Pre-assignment Details

Stage 1 interim analysis met the prespecified futility threshold for the primary efficacy endpoint, satisfying the clinical criteria for early trial termination (futility). As a result, the trial was terminated at Stage 1; did not proceed to Stage 2.

In stage 1: 1 randomized participant received no study medication (MK-7622 High Dose-45 mg arm).

Arm/Group Title MK-7622 High Dose - 45 mg (Stage 1) Placebo (Stage 1) MK-7622 Low Dose - 5 mg (Stage 2) MK-7622 Mid Dose - 15 mg (Stage 2) MK-7622 High Dose - 45 mg (Stage 2) Placebo (Stage 2)
Hide Arm/Group Description Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment. Matching placebo to MK-7622 capsule once daily, taken orally. Single 5 mg MK-7622 capsule once daily, taken orally. Single 15 mg MK-7622 capsule once daily, taken orally. Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment. Matching placebo to MK-7622 capsule once daily, taken orally.
Period Title: Overall Study
Started 120 120 0 [1] 0 [1] 0 [1] 0 [1]
Treated 119 120 0 0 0 0
Completed 70 74 0 [1] 0 [1] 0 [1] 0 [1]
Not Completed 50 46 0 0 0 0
Reason Not Completed
Adverse Event             12             5             0             0             0             0
Lost to Follow-up             1             3             0             0             0             0
Non-compliance with Study Drug             2             1             0             0             0             0
Physician Decision             1             0             0             0             0             0
Protocol Violation             0             1             0             0             0             0
Study Terminated by Sponsor             30             32             0             0             0             0
Withdrawal by Subject             4             4             0             0             0             0
[1]
Study terminated prior to participant recruitment for Stage 2
Arm/Group Title MK-7622 High Dose - 45 mg (Stage 1) Placebo (Stage 1) Total
Hide Arm/Group Description Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment. Matching placebo to MK-7622 capsule once daily, taken orally. Total of all reporting groups
Overall Number of Baseline Participants 119 120 239
Hide Baseline Analysis Population Description
Includes only participants in Stage 1 who were both randomized (i.e. started) and treated. In stage 1: MK-7622 High Dose - 45 mg: of the randomized participants (n=120), all but 1 randomized participant received study treatment (n=119). Placebo: Of the randomized participants (n=120), all received study treatment (n=120).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 119 participants 120 participants 239 participants
72.5  (7.1) 71.7  (8.3) 72.1  (7.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 120 participants 239 participants
Female
61
  51.3%
68
  56.7%
129
  54.0%
Male
58
  48.7%
52
  43.3%
110
  46.0%
11-item Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Score on a Scale
Number Analyzed 119 participants 120 participants 239 participants
21.8  (7.05) 23.6  (8.73) 22.7  (7.95)
[1]
Measure Description: ADAS-Cog11 measures cognition by assessing 11 metrics impaired in Alzheimer's Disease (AD): speech; speech comprehension; word finding; word recall; object/finger naming; orientation; obeying commands; ideational praxis; constructional praxis; word recognition; and remembering instruction. For each metric, scores range from 0 (no impairment) to (depending on the metric) either 5 (8 metrics), 8, 10, or 12 (1 metric each); higher scores indicate more severe impairment. Individual scores sum to a total ADAS-Cog11 score (range: 0-70). Higher total scores indicate greater cognitive impairment.
[2]
Measure Analysis Population Description: Includes only randomized participants receiving ≥1 dose of study medication, having a baseline ADAS-Cog11 assessment.
Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Score on a Scale
Number Analyzed 119 participants 119 participants 238 participants
60.7  (11.18) 59.4  (11.89) 59.9  (11.72)
[1]
Measure Description: The ADCS-ADL score measures the performance of activities of daily living, calculated from a 24-question survey. For each of the 24 questions, scores range from 0 (no independence) to (depending on the question) either 2 (1 question), 3 (17 questions), 4 (5 questions), or 5 (1 question), with higher scores indicating greater independence in activity performance. Scores from individual questions are summed into a total ADCS-ADL score, with potential total scores ranging from 0 to 78. Lower scores indicate less independence in activity performance and, as a result, greater AD severity.
[2]
Measure Analysis Population Description: Includes only randomized participants receiving ≥1 dose of study medication, having a baseline ADCS-ADL assessment.
Composite Cognition Score-3 Domain (CCS-3D)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Z-score
Number Analyzed 108 participants 110 participants 218 participants
-0.11  (0.739) 0.02  (0.816) -0.039  (0.776)
[1]
Measure Description: CCS-3D is composed of individual cognitive tests, grouped into 3 domains: 1) episodic memory; 2) executive function; and 3) attention/processing speed. For each cognitive test, a z-score (Z) is calculated at each time point [Z = (observed value - study population mean at baseline) / study population standard deviation at baseline]. These individual Zs are first combined into domain-specific Zs, and then into a composite Z, (i.e. CCS-3D). Theoretically, 99.9% of CCS-3D will be ± 3; more positive CCS-3D indicate greater cognitive impairment relative to the total study population at baseline.
[2]
Measure Analysis Population Description: Includes only randomized participants receiving ≥1 dose of study medication, having a baseline CCS-3D assessment.
1.Primary Outcome
Title Change From Baseline in the 11-item Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at Week 12 (Stage 1, MK-7622 45 mg Versus Placebo)
Hide Description Mean change from baseline at week 12 was assessed for ADAS-Cog11 score. ADAS-Cog11 measures cognition by assessing 11 metrics impaired in Alzheimer's Disease (AD): speech; speech comprehension; word finding; word recall; object/finger naming; orientation; obeying commands; ideational praxis; constructional praxis; word recognition; and remembering instruction. For each metric, scores range from 0 (no impairment) to (depending on the metric) either 5 (8 metrics), 8, 10, or 12 (1 metric each); higher scores indicate more severe impairment. Individual scores sum to a total ADAS-Cog11 score, ranging from 0-70. Higher total scores indicate greater cognitive impairment and AD severity. Further, increases in AD severity over time would be reflected by increases in ADAS-Cog11 score.
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in Stage 1 receiving ≥1 dose of study medication, having either a baseline or 12-week ADAS-Cog11 assessment.
Arm/Group Title MK-7622 High Dose - 45 mg (Stage 1) Placebo (Stage 1)
Hide Arm/Group Description:
Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment.
Matching placebo to MK-7622 capsule once daily, taken orally.
Overall Number of Participants Analyzed 119 120
Mean (Standard Error)
Unit of Measure: Score on a Scale
0.39  (0.440) 0.21  (0.416)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-7622 High Dose - 45 mg (Stage 1), Placebo (Stage 1)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7623
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.18
Confidence Interval (2-Sided) 95%
-1.00 to 1.37
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in ADAS-Cog11 Score at Week 12 (Stage 2, MK-7622 45 mg and 15 mg Versus Placebo)
Hide Description Mean change from baseline at week 12 was assessed for ADAS-Cog11 score. ADAS-Cog11 measures cognition by assessing 11 metrics impaired in Alzheimer's Disease (AD): speech; speech comprehension; word finding; word recall; object/finger naming; orientation; obeying commands; ideational praxis; constructional praxis; word recognition; and remembering instruction. For each metric, scores range from 0 (no impairment) to (depending on the metric) either 5 (8 metrics), 8, 10, or 12 (1 metric each); higher scores indicate more severe impairment. Individual scores sum to a total ADAS-Cog11 score, ranging from 0-70. Higher total scores indicate greater cognitive impairment and AD severity. Further, increases in AD severity over time would be reflected by increases in ADAS-Cog11 score.
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per study protocol, the analysis population was to include only randomized participants in Stage 2 receiving ≥1 dose of placebo, MK-7622 - 15 mg, or MK-7622 - 45 mg, having either a baseline or 12-week ADAS-Cog11 assessment. Study terminated before Stage 2 enrollment; no data were collected for this outcome measure.
Arm/Group Title MK-7622 Mid Dose - 15 mg (Stage 2) MK-7622 High Dose - 45 mg (Stage 2) Placebo (Stage 2)
Hide Arm/Group Description:
Single 15 mg MK-7622 capsule once daily, taken orally.
Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment.
Matching placebo to MK-7622 capsule once daily, taken orally.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Number of Participants Experiencing an Adverse Event (AE)
Hide Description The number of participants experiencing an adverse event (AE) was assessed. An AE is any unfavorable and unintended medical occurrence, symptom, or disease witnessed in a participant, regardless of whether or not a causal relationship with the study treatment can be demonstrated. Further, any worsening of a preexisting condition that is temporally associated with the use of the study treatment is also considered an AE.
Time Frame Up to 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants as treated, consisting of all participants (Stages 1 and 2) who received study medication. Study terminated before Stage 2 enrollment; no data were collected for Stage 2-specific arms.
Arm/Group Title MK-7622 High Dose - 45 mg (Stage 1) Placebo (Stage 1) MK-7622 Low Dose - 5 mg (Stage 2) MK-7622 Mid Dose - 15 mg (Stage 2) MK-7622 High Dose - 45 mg (Stage 2) Placebo (Stage 2)
Hide Arm/Group Description:
Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment.
Matching placebo to MK-7622 capsule once daily, taken orally.
Single 5 mg MK-7622 capsule once daily, taken orally.
Single 15 mg MK-7622 capsule once daily, taken orally.
Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment.
Matching placebo to MK-7622 capsule once daily, taken orally.
Overall Number of Participants Analyzed 119 120 0 0 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
83
  69.7%
71
  59.2%
4.Primary Outcome
Title Number of Participants Who Discontinued Study Drug Due to an AE
Hide Description The number of participants discontinuing study drug due to an AE was assessed.
Time Frame Up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants as treated, consisting of all participants (Stages 1 and 2) who received study medication. Study terminated before Stage 2 enrollment; no data were collected for Stage 2-specific arms.
Arm/Group Title MK-7622 High Dose - 45 mg (Stage 1) Placebo (Stage 1) MK-7622 Low Dose - 5 mg (Stage 2) MK-7622 Mid Dose - 15 mg (Stage 2) MK-7622 High Dose - 45 mg (Stage 2) Placebo (Stage 2)
Hide Arm/Group Description:
Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment.
Matching placebo to MK-7622 capsule once daily, taken orally.
Single 5 mg MK-7622 capsule once daily, taken orally, for 24 weeks
Single 15 mg MK-7622 capsule once daily, taken orally.
Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment.
Matching placebo to MK-7622 capsule once daily, taken orally.
Overall Number of Participants Analyzed 119 120 0 0 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
19
  16.0%
7
   5.8%
5.Secondary Outcome
Title Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL) at Week 24 (Combining Stage 1 and 2, MK-7622 45 mg Versus Placebo)
Hide Description Mean change from baseline at week 24 was assessed for ADCS-ADL score. The ADCS-ADL score measures the performance of activities of daily living, calculated from a 24-question survey. For each of the 24 questions, scores range from 0 (no independence) to (depending on the question) either 2 (1 question), 3 (17 questions), 4 (5 questions), or 5 (1 question), with higher scores indicating greater independence in activity performance. Scores from individual questions are summed into a total ADCS-ADL score, with potential total scores ranging from 0 to 78. Lower scores indicate less independence in activity performance and, as a result, greater AD severity. Further, increases in AD severity over time would be reflected by decreases in ADCS-ADL score.
Time Frame Baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, analysis population was to include all randomized participants (pooled across Stages 1 and 2) receiving ≥1 dose of placebo or MK-7622 - 45 mg, having either a baseline or 24-week ADCS-ADL assessment. As the study was terminated before Stage 2 enrollment, only participants in Stage 1 were analyzed.
Arm/Group Title MK-7622 High Dose - 45 mg (Stage 1) Placebo (Stage 1)
Hide Arm/Group Description:
Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment.
Matching placebo to MK-7622 capsule once daily, taken orally.
Overall Number of Participants Analyzed 119 119
Mean (Standard Error)
Unit of Measure: Score on a Scale
-2.66  (0.919) -2.73  (0.853)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-7622 High Dose - 45 mg (Stage 1), Placebo (Stage 1)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9604
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-2.42 to 2.54
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Composite Cognition Score-3 Domain (CCS-3D) at Week 12 (Stage 1, MK-7622 45 mg Versus Placebo)
Hide Description CCS-3D is composed of individual cognitive tests, grouped into 3 domains: 1) episodic memory; 2) executive function; and 3) attention/processing speed. For each cognitive test, a z-score (Z) is calculated at each time point [Z = (observed value - study population mean at baseline) / study population standard deviation at baseline]. These individual Zs are first combined into domain-specific Zs, and then into a composite Z, (i.e. CCS-3D). Theoretically, 99.9% of CCS-3D will be ± 3; more positive CCS-3D indicate greater cognitive impairment relative to the total study population at baseline. Further, negative changes in CCS-3D over time indicate improved cognition relative to the total study population at baseline.
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in Stage 1 receiving ≥1 dose of study medication, having either a baseline or 12-week CCS-3D assessment.
Arm/Group Title MK-7622 High Dose - 45 mg (Stage 1) Placebo (Stage 1)
Hide Arm/Group Description:
Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment.
Matching placebo to MK-7622 capsule once daily, taken orally.
Overall Number of Participants Analyzed 108 110
Mean (Standard Error)
Unit of Measure: z-score
0.13  (0.043) 0.03  (0.042)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-7622 High Dose - 45 mg (Stage 1), Placebo (Stage 1)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0829
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
-0.01 to 0.22
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in CCS-3D at Week 12 (Stage 2, MK-7622 45 mg and 15 mg Versus Placebo)
Hide Description CCS-3D is composed of individual cognitive tests, grouped into 3 domains: 1) episodic memory; 2) executive function; and 3) attention/processing speed. For each cognitive test, a z-score (Z) is calculated at each time point [Z = (observed value - study population mean at baseline) / study population standard deviation at baseline]. These individual Zs are first combined into domain-specific Zs, and then into a composite Z, (i.e. CCS-3D). Theoretically, 99.9% of CCS-3D will be ± 3; more positive CCS-3D indicate greater cognitive impairment relative to the total study population at baseline. Further, negative changes in CCS-3D over time indicate improved cognition relative to the total study population at baseline.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per study protocol, the analysis population was to include only randomized participants in Stage 2 receiving ≥1 dose of placebo, MK-7622 - 15 mg, or MK-7622 - 45 mg, having either a baseline or 12-week CCS-3D assessment. Study terminated before Stage 2 enrollment; no data were collected for this outcome measure.
Arm/Group Title MK-7622 Mid Dose - 15 mg (Stage 2) MK-7622 High Dose - 45 mg (Stage 2) Placebo (Stage 2)
Hide Arm/Group Description:
Single 15 mg MK-7622 capsule once daily, taken orally.
Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment.
Matching placebo to MK-7622 capsule once daily, taken orally.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to 26 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MK-7622 High Dose - 45 mg (Stage 1) Placebo (Stage 1)
Hide Arm/Group Description Single 45 mg MK-7622 capsule once daily, taken orally. Dose escalated as follows: 15 mg MK-7622 once daily for 1 week; 30 mg MK-7622 once daily for 1 week; and 45 mg MK-7622 once daily for the remainder of treatment. Matching placebo to MK-7622 capsule once daily, taken orally.
All-Cause Mortality
MK-7622 High Dose - 45 mg (Stage 1) Placebo (Stage 1)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
MK-7622 High Dose - 45 mg (Stage 1) Placebo (Stage 1)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/119 (7.56%)      4/120 (3.33%)    
Cardiac disorders     
Bradycardia  1  1/119 (0.84%)  1 0/120 (0.00%)  0
Gastrointestinal disorders     
Pancreatitis acute  1  0/119 (0.00%)  0 1/120 (0.83%)  1
General disorders     
Fatigue  1  1/119 (0.84%)  1 0/120 (0.00%)  0
Infections and infestations     
Upper respiratory tract infection  1  1/119 (0.84%)  1 0/120 (0.00%)  0
Urinary tract infection  1  0/119 (0.00%)  0 2/120 (1.67%)  2
Injury, poisoning and procedural complications     
Eye injury  1  0/119 (0.00%)  0 1/120 (0.83%)  1
Fall  1  0/119 (0.00%)  0 2/120 (1.67%)  2
Metabolism and nutrition disorders     
Dehydration  1  0/119 (0.00%)  0 1/120 (0.83%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cholangiocarcinoma  1  1/119 (0.84%)  1 0/120 (0.00%)  0
Lung neoplasm malignant  1  1/119 (0.84%)  1 0/120 (0.00%)  0
Prostate cancer  1  1/119 (0.84%)  1 0/120 (0.00%)  0
Nervous system disorders     
Ischaemic stroke  1  1/119 (0.84%)  1 0/120 (0.00%)  0
Normal pressure hydrocephalus  1  1/119 (0.84%)  1 0/120 (0.00%)  0
Syncope  1  0/119 (0.00%)  0 1/120 (0.83%)  1
Psychiatric disorders     
Bipolar I disorder  1  1/119 (0.84%)  1 0/120 (0.00%)  0
Mental status changes  1  1/119 (0.84%)  1 0/120 (0.00%)  0
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  1/119 (0.84%)  1 0/120 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MK-7622 High Dose - 45 mg (Stage 1) Placebo (Stage 1)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   42/119 (35.29%)      20/120 (16.67%)    
Gastrointestinal disorders     
Diarrhoea  1  18/119 (15.13%)  19 7/120 (5.83%)  9
Infections and infestations     
Urinary tract infection  1  6/119 (5.04%)  7 5/120 (4.17%)  6
Investigations     
Weight decreased  1  6/119 (5.04%)  6 2/120 (1.67%)  2
Nervous system disorders     
Headache  1  11/119 (9.24%)  12 6/120 (5.00%)  7
Renal and urinary disorders     
Urinary incontinence  1  6/119 (5.04%)  6 0/120 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Rhinorrhoea  1  7/119 (5.88%)  7 1/120 (0.83%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Stage 1 Interim analysis of efficacy met the clinical criteria for early trial termination (futility). As a result, the trial was terminated at Stage 1 and did not proceed to Stage 2.
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 Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT01852110    
Other Study ID Numbers: 7622-012
2013-000937-11 ( EudraCT Number )
MK-7622-012 ( Other Identifier: Merck Protocol Number )
First Submitted: May 8, 2013
First Posted: May 13, 2013
Results First Submitted: January 8, 2018
Results First Posted: February 7, 2018
Last Update Posted: September 18, 2018