Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04605549 | A Study of CIN-107 in Adults With Primary Aldosteronism | PHASE2 | COMPLETED | 15 | — | — | Mar 8, 2021 | Oct 28, 2024 | Mar 3, 2026 | 10 | United States |
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Adverse events were collected from the beginning of the study until Week 74. Treatment emergent AEs are defined as AEs that newly occur or worsen in severity during the treatment period.
The mean seated SBP was defined as the average of 3 measurements obtained at the clinical site visit. The change from baseline in mean seated SBP after 12 weeks of treatment with CIN-107 (Part 1) is calculated.
| Arm | Type | Description |
|---|---|---|
| CIN-107 for dosing at 2, 4, or 8 mg (QD) | EXPERIMENTAL | Patients will be provided with an initial dose of CIN-107 and start once daily (QD) dosing of CIN-107 tablets at 2 mg. At Visit 4, CIN-107 dose may be up-titrated to 4 mg QD if the patient has tolerated dosing of CIN-107 at 2 mg and the blood pressure (BP) records indicate minimal hypotension risk. At Visit 5, CIN-107 dose may be up-titrated to 8 mg QD if the patient has tolerated dosing of CIN-107 at 4 mg. |
| Name | Type | Description |
|---|---|---|
| CIN-107 2 mg dosing | DRUG | One tablet of CIN-107 2 mg tablets, once daily, by mouth, for dosing at 2 mg. |
| CIN-107 4 mg dosing | DRUG | Two tablets of CIN-107 2 mg tablets, once daily, by mouth, for dosing at 4 mg. |
| CIN-107 8 mg dosing | DRUG | Four tablets of CIN-107 2 mg tablets, once daily, by mouth, for dosing at 8 mg. |
Inclusion Criteria: 1. Have been diagnosed with PA. 2. Are taking mineralocorticoid receptor antagonist (MRA) to control BP; or are newly diagnosed with PA and have not started MRA treatment. 3. Are willing and able to cease dosing of MRA for up to 4 weeks in patients taking MRA. 4. Are willing to ...