Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007_600 |
Not provided
Not provided
Not provided
Lack of recruitment
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| FoxHollow Technologies | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A 12-Week Efficacy Study in participants with Peripheral Arterial Disease. the primary hypothesis is that MK-0736 7 mg administered once daily for 12 weeks will result in a decrease in lower extremity atherosclerotic plaque macrophage content when compared to placebo (an approximate decrease of up to 30% is expected).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-0736 | Experimental | Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks |
|
| Placebo | Placebo Comparator | Participants will be orally administered placebo once daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-0736 | Drug | MK-0736; 7mg once daily, orally at approximately the same time each morning for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Cluster of Differentiation 68 (CD68) | CD68 is a heavily glycosylated transmembrane protein resident to macrophage lysosomes, and is the standard immunohistochemical (IHC) marker for macrophages in human tissues. CD68 protein content as a measure of macrophage number is the most often reported marker in clinical studies of plaque instability. Blood samples were taken to determine the level of CD69 present at baseline (predose Day 1) and again after 12 weeks of study drug administration in participants with peripheral arterial disease of the lower extremity who are scheduled for excision of an atherosclerotic plaque. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Messenger Ribonucleic Acid (mRNA) | mRNA is a biomarker associated with the inflammatory response. Blood samples were taken to determine the level of mRNA present at baseline (predose Day 1) and again after 12 weeks of study drug administration in participants with peripheral arterial disease of the lower extremity who are scheduled for excision of an atherosclerotic plaque. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
Not provided
Not provided
| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | MK-0736 | Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks |
| FG001 | Placebo | Participants will be orally administered placebo once daily for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MK-0736 | Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks |
| BG001 | Placebo | Participants will be orally administered placebo once daily for 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Cluster of Differentiation 68 (CD68) | CD68 is a heavily glycosylated transmembrane protein resident to macrophage lysosomes, and is the standard immunohistochemical (IHC) marker for macrophages in human tissues. CD68 protein content as a measure of macrophage number is the most often reported marker in clinical studies of plaque instability. Blood samples were taken to determine the level of CD69 present at baseline (predose Day 1) and again after 12 weeks of study drug administration in participants with peripheral arterial disease of the lower extremity who are scheduled for excision of an atherosclerotic plaque. | Study terminated early. Planned analyses was not performed. | Posted | Baseline and Week 12 |
|
up to 14 weeks
All enrolled participants who recieved at least one dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MK-0736 | Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure acute | Cardiac disorders | MedDRA version 15.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA version 15.1 | Systematic Assessment |
Study terminated due to lack of recruitment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Comparator: placebo (unspecified) | Drug | Matching Placebo once daily, orally at approximately the same time each morning for 12 weeks. |
|
| Baseline and Week 12 |
| Number of Participants Who Were Discontinued From the Study Due to an Adverse Event (AE) | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the study drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. The percentage of participants who were discontinued from the study due to an AE was summarized. | up to 14 weeks |
| Study Terminated |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Placebo |
Participants will be orally administered placebo once daily for 12 weeks. |
|
| Secondary | Change From Baseline in Messenger Ribonucleic Acid (mRNA) | mRNA is a biomarker associated with the inflammatory response. Blood samples were taken to determine the level of mRNA present at baseline (predose Day 1) and again after 12 weeks of study drug administration in participants with peripheral arterial disease of the lower extremity who are scheduled for excision of an atherosclerotic plaque. | Study terminated early. Planned analyses was not performed. | Posted | Baseline and Week 12 |
|
|
| Secondary | Number of Participants Who Were Discontinued From the Study Due to an Adverse Event (AE) | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the study drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. The percentage of participants who were discontinued from the study due to an AE was summarized. | All enrolled participants who received at least one dose of study drug. | Posted | Number | Particpants | up to 14 weeks |
|
|
|
| 1 |
| 8 |
| 5 |
| 8 |
| EG001 | Placebo | Participants will be orally administered placebo once daily for 12 weeks. | 1 | 6 | 4 | 6 |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA version 15.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA version 15.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA version 15.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA version 15.1 | Systematic Assessment |
|
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA version 15.1 | Systematic Assessment |
|
| Tachyarrhythmia | Cardiac disorders | MedDRA version 15.1 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA version 15.1 | Systematic Assessment |
|
| Ileus paralytic | Gastrointestinal disorders | MedDRA version 15.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA version 15.1 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA version 15.1 | Systematic Assessment |
|
| Hepatic congestion | Hepatobiliary disorders | MedDRA version 15.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA version 15.1 | Systematic Assessment |
|
| Infectious mononucleosis | Infections and infestations | MedDRA version 15.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA version 15.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA version 15.1 | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA version 15.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 15.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 15.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 15.1 | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA version 15.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 15.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 15.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 15.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA version 15.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 15.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA version 15.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA version 15.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA version 15.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.1 | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 15.1 | Systematic Assessment |
|
The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.