Trial Outcomes & Findings for Carotid IMT (Intima Media Thickening) Study (0524A-041)(TERMINATED) (NCT NCT00384293)
NCT ID: NCT00384293
Last Updated: 2015-09-30
Results Overview
change in mean carotid intima media thickness defined as a composite measure of the left and right common, bulb, and internal carotid artery.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
937 participants
Primary outcome timeframe
after 96 weeks of postrandomization treatment
Results posted on
2015-09-30
Participant Flow
There was an MK0524A active run-in period prior to randomization. Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, for an additional 4 weeks prior to randomization.
Participant milestones
| Measure |
MK0524A Active Run-In Period
Patients who received MK0524A during active run-in (Visit 2). Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, at Visit 3 for an additional 4 weeks prior to randomization.
|
MK0524A, 2 g (Postrandomization Period)
Patients who were randomized to MK0524A, 2 g (oral administration) once daily.
|
Placebo (Postrandomization Period)
Patients who were randomized to placebo
|
|---|---|---|---|
|
MK0524A Active Run-In, Pre-randomization
STARTED
|
937
|
0
|
0
|
|
MK0524A Active Run-In, Pre-randomization
Entered Active run-in, MK0524A 1 g
|
937
|
0
|
0
|
|
MK0524A Active Run-In, Pre-randomization
MK0524A Dose Increased to 2 g
|
813
|
0
|
0
|
|
MK0524A Active Run-In, Pre-randomization
COMPLETED
|
433
|
0
|
0
|
|
MK0524A Active Run-In, Pre-randomization
NOT COMPLETED
|
504
|
0
|
0
|
|
Post-randomization Period
STARTED
|
0
|
214
|
219
|
|
Post-randomization Period
Received ≥1 Dose of MK0524A Study Drug
|
0
|
214
|
218
|
|
Post-randomization Period
COMPLETED
|
0
|
0
|
0
|
|
Post-randomization Period
NOT COMPLETED
|
0
|
214
|
219
|
Reasons for withdrawal
| Measure |
MK0524A Active Run-In Period
Patients who received MK0524A during active run-in (Visit 2). Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, at Visit 3 for an additional 4 weeks prior to randomization.
|
MK0524A, 2 g (Postrandomization Period)
Patients who were randomized to MK0524A, 2 g (oral administration) once daily.
|
Placebo (Postrandomization Period)
Patients who were randomized to placebo
|
|---|---|---|---|
|
MK0524A Active Run-In, Pre-randomization
Adverse Event
|
120
|
0
|
0
|
|
MK0524A Active Run-In, Pre-randomization
Lost to Follow-up
|
1
|
0
|
0
|
|
MK0524A Active Run-In, Pre-randomization
Withdrawal by Subject
|
24
|
0
|
0
|
|
MK0524A Active Run-In, Pre-randomization
Not cIMT eligible at Visit 3
|
340
|
0
|
0
|
|
MK0524A Active Run-In, Pre-randomization
Trial Termination
|
16
|
0
|
0
|
|
MK0524A Active Run-In, Pre-randomization
Certified Sonographer Not Available
|
2
|
0
|
0
|
|
MK0524A Active Run-In, Pre-randomization
Patient Unable to Complete cIMT Scan
|
1
|
0
|
0
|
|
Post-randomization Period
Adverse Event
|
0
|
23
|
7
|
|
Post-randomization Period
Lost to Follow-up
|
0
|
2
|
1
|
|
Post-randomization Period
Protocol Violation
|
0
|
1
|
0
|
|
Post-randomization Period
Withdrawal by Subject
|
0
|
8
|
6
|
|
Post-randomization Period
Trial Termination
|
0
|
180
|
204
|
|
Post-randomization Period
Patient Randomized in Error
|
0
|
0
|
1
|
Baseline Characteristics
Carotid IMT (Intima Media Thickening) Study (0524A-041)(TERMINATED)
Baseline characteristics by cohort
| Measure |
MK0524A, 2 g (Postrandomization Period)
n=214 Participants
Patients who were randomized to MK0524A, 2 g (oral administration) once daily.
|
Placebo (Postrandomization Period)
n=218 Participants
Patients who were randomized to placebo
|
Total
n=432 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.1 years
STANDARD_DEVIATION 8.94 • n=99 Participants
|
54.5 years
STANDARD_DEVIATION 8.22 • n=107 Participants
|
53.8 years
STANDARD_DEVIATION 8.60 • n=206 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=99 Participants
|
82 Participants
n=107 Participants
|
158 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
138 Participants
n=99 Participants
|
136 Participants
n=107 Participants
|
274 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: after 96 weeks of postrandomization treatmentPopulation: study prematurely terminated, no efficacy analyses were performed
change in mean carotid intima media thickness defined as a composite measure of the left and right common, bulb, and internal carotid artery.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: after 96 weeks of postrandomization treatmentPopulation: study prematurely terminated, no efficacy analyses were performed
Outcome measures
Outcome data not reported
Adverse Events
MK0524A Active Run-In Period
Serious events: 10 serious events
Other events: 395 other events
Deaths: 0 deaths
MK0524A, 2 g (Postrandomization Period)
Serious events: 5 serious events
Other events: 74 other events
Deaths: 0 deaths
Placebo (Postrandomization Period)
Serious events: 8 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MK0524A Active Run-In Period
Patients who received MK0524A during active run-in (Visit 2). Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, at Visit 3 for an additional 4 weeks prior to randomization.
|
MK0524A, 2 g (Postrandomization Period)
Patients who were randomized to MK0524A, 2 g (oral administration) once daily.
|
Placebo (Postrandomization Period)
Patients who were randomized to placebo
|
|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/937
|
0.00%
0/214
|
0.46%
1/218
|
|
Cardiac disorders
Acute myocardial infarction
|
0.11%
1/937
|
0.00%
0/214
|
0.00%
0/218
|
|
Cardiac disorders
Acute pectoris
|
0.00%
0/937
|
0.47%
1/214
|
0.00%
0/218
|
|
Cardiac disorders
Angina unstable
|
0.11%
1/937
|
0.47%
1/214
|
0.46%
1/218
|
|
Cardiac disorders
Atrial fibrillation
|
0.11%
1/937
|
0.00%
0/214
|
0.00%
0/218
|
|
Cardiac disorders
Myocardial infarction
|
0.11%
1/937
|
0.00%
0/214
|
0.00%
0/218
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/937
|
0.00%
0/214
|
0.46%
1/218
|
|
Gastrointestinal disorders
Constipation
|
0.11%
1/937
|
0.00%
0/214
|
0.00%
0/218
|
|
General disorders
Pyrexia
|
0.00%
0/937
|
0.00%
0/214
|
0.46%
1/218
|
|
Hepatobiliary disorders
Hepatitis
|
0.11%
1/937
|
0.00%
0/214
|
0.00%
0/218
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/937
|
0.00%
0/214
|
0.46%
1/218
|
|
Infections and infestations
Diverticulitis
|
0.11%
1/937
|
0.00%
0/214
|
0.00%
0/218
|
|
Infections and infestations
Staphylococcal sepsis
|
0.11%
1/937
|
0.00%
0/214
|
0.00%
0/218
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/937
|
0.00%
0/214
|
0.46%
1/218
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.11%
1/937
|
0.00%
0/214
|
0.00%
0/218
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/937
|
0.93%
2/214
|
0.00%
0/218
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/937
|
0.47%
1/214
|
0.46%
1/218
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/937
|
0.00%
0/214
|
0.46%
1/218
|
|
Musculoskeletal and connective tissue disorders
Toe deformity
|
0.00%
0/937
|
0.00%
0/214
|
0.46%
1/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.11%
1/937
|
0.00%
0/214
|
0.00%
0/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.11%
1/937
|
0.00%
0/214
|
0.00%
0/218
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/937
|
0.00%
0/214
|
0.46%
1/218
|
|
Renal and urinary disorders
Renal failure acute
|
0.11%
1/937
|
0.00%
0/214
|
0.00%
0/218
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/937
|
0.47%
1/214
|
0.00%
0/218
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/937
|
0.00%
0/214
|
0.46%
1/218
|
|
Vascular disorders
Arterial stenosis
|
0.11%
1/937
|
0.00%
0/214
|
0.00%
0/218
|
Other adverse events
| Measure |
MK0524A Active Run-In Period
Patients who received MK0524A during active run-in (Visit 2). Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, at Visit 3 for an additional 4 weeks prior to randomization.
|
MK0524A, 2 g (Postrandomization Period)
Patients who were randomized to MK0524A, 2 g (oral administration) once daily.
|
Placebo (Postrandomization Period)
Patients who were randomized to placebo
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
20/937
|
3.7%
8/214
|
1.8%
4/218
|
|
Gastrointestinal disorders
Nausea
|
2.6%
24/937
|
2.3%
5/214
|
0.00%
0/218
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/937
|
2.3%
5/214
|
0.00%
0/218
|
|
General disorders
Fatigue
|
0.00%
0/937
|
2.8%
6/214
|
2.3%
5/218
|
|
Infections and infestations
Influenza
|
0.00%
0/937
|
6.5%
14/214
|
8.3%
18/218
|
|
Infections and infestations
Nasopharyngitis
|
2.5%
23/937
|
6.5%
14/214
|
6.0%
13/218
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/937
|
1.9%
4/214
|
2.8%
6/218
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/937
|
3.7%
8/214
|
1.4%
3/218
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/937
|
3.7%
8/214
|
2.8%
6/218
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/937
|
2.8%
6/214
|
3.7%
8/218
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/937
|
0.93%
2/214
|
3.2%
7/218
|
|
Nervous system disorders
Headache
|
5.5%
52/937
|
4.7%
10/214
|
2.3%
5/218
|
|
Nervous system disorders
Paraesthesia
|
5.0%
47/937
|
0.00%
0/214
|
0.00%
0/218
|
|
Nervous system disorders
Burning Sensation
|
2.7%
25/937
|
0.00%
0/214
|
0.00%
0/218
|
|
Nervous system disorders
Dizziness
|
2.2%
21/937
|
0.00%
0/214
|
0.00%
0/218
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
78/937
|
4.7%
10/214
|
0.92%
2/218
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.5%
23/937
|
0.00%
0/214
|
0.00%
0/218
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.3%
22/937
|
0.00%
0/214
|
0.00%
0/218
|
|
Vascular disorders
Flushing
|
19.6%
184/937
|
2.3%
5/214
|
0.00%
0/218
|
|
Vascular disorders
Hot flush
|
3.9%
37/937
|
0.00%
0/214
|
0.00%
0/218
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER