Table 2.
Efficacy and safety parameter assessment schedule
| Study plan | Screening | Treatment | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit number | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13/ETa |
| Week number* | − 6 | − 4 | − 2 | 0 | 6 | 13 | 26 | 39 | 52 | 65 | 78 | 91 | 104 |
| Informed consent | ✓ | ||||||||||||
| Randomisation | ✓ | ||||||||||||
| Vital signs | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
| Height | ✓ | ||||||||||||
| Body weight | ✓ | ✓ | ✓ | ||||||||||
| Adverse events | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
| Concomitant medications | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| Medical history | ✓ | ||||||||||||
| Physical examination | ✓ | ✓ | |||||||||||
| ECG | ✓ | ✓ | |||||||||||
| Chemistry panel | ✓b | ✓ | ✓ | ✓ | ✓c | ✓c | ✓c | ✓ | |||||
| Pregnancy testd | ✓ | ||||||||||||
| Haematology | ✓ | ✓ | |||||||||||
| Urine samplee | ✓ | ✓ | |||||||||||
| Serum lipid profile | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
| ApoA-I and ApoB | ✓ | ✓ | |||||||||||
| Risk assessment | ✓ | ||||||||||||
| IMT | ✓f | ✓f | ✓ | ✓ | ✓ | ✓✓g | |||||||
| Dispense investigational product | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
| Investigational product compliance | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||||
| TLC counsellingh | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
ALP alkaline phosphatase, ALT alanine aminotransferase, Apo apolipoprotein, AST aspartate aminotransferase, CK creatine kinase, ECG electrocardiogram, ET early termination, IMT intima-media thickness, TLC therapeutic lifestyle changes, TSH thyroid-stimulating hormone
*The visit window for all study visits is ± 7 days
aIn the event of early termination, all non-IMT procedures scheduled for visit 13 (week 104) are to be conducted. A single IMT is to be performed on any subject who withdraws after 26 weeks
bIncluding TSH at visit 1
cAbbreviated chemistry panel including liver function tests (ALT, AST, bilirubin, ALP), serum creatinine, and CK only
dUrine pregnancy test conducted at the study site. Required only for premenopausal women. Those with amenorrhoea for at least 1 year are exempt
eFor complete urinalysis
fIMT measurements at visit 2 (week − 4) and visit 3 (week − 2) must meet the inclusion criteria of maximum IMT ≥ 1.2 mm and < 3.5 mm
gFinal IMT procedures will be scheduled before discontinuation of study treatment. The second and final IMT procedures should occur at or before visit 13 (week 104), at the time of discontinuation of the study treatment. The two IMT procedures for visit 13 should be performed on different days when possible
hTLC counselling is to be reinforced at each clinic visit