Coronary artery disease
Conditions
Brief summary
Percentage change from baseline in coagulation factor XI activity at Week 8, compared with placebo.
Detailed description
1. Frequency, intensity, and seriousness of AEs during the trial, as well as clinically significant changes in laboratory parameters, vital signs, physical examinations, and 12-lead ECGs, 2. Plasma concentrations of RBD1119, summarized with descriptive statistics by dose and sampling timepoint, 3. Change from baseline and percentage change from baseline in coagulation factor XI activity after dosing of RBD1119, compared with placebo, over the trial period, 4. Change from baseline and percentage change from baseline in aPTT, PT/INR and coagulation factor XI antigen levels after dosing of RBD1119, compared with placebo, over the trial period.
Interventions
Sponsors
Ribocure Pharmaceuticals AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change from baseline in coagulation factor XI activity at Week 8, compared with placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Frequency, intensity, and seriousness of AEs during the trial, as well as clinically significant changes in laboratory parameters, vital signs, physical examinations, and 12-lead ECGs, 2. Plasma concentrations of RBD1119, summarized with descriptive statistics by dose and sampling timepoint, 3. Change from baseline and percentage change from baseline in coagulation factor XI activity after dosing of RBD1119, compared with placebo, over the trial period, 4. Change from baseline and percentage change from baseline in aPTT, PT/INR and coagulation factor XI antigen levels after dosing of RBD1119, compared with placebo, over the trial period. | — |
Outcome results
None listed