Clinical trial
A Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, and Effectiveness of CIN-107 for the Management of Blood Pressure in Patients With Primary Aldosteronism
Name
CIN-107-122
Description
This is a multicenter, open-label study in adult patients with PA to evaluate the effectiveness and safety of CIN-107 after up to 12 weeks of treatment (Part 1), and then for eligible, consenting patients follow patients in Part 2 for up to 74 weeks for evidence of long-term safety and tolerability.
Trial arms
Trial start
2021-03-08
Estimated PCD
2024-10-10
Trial end
2024-10-10
Status
Active (not recruiting)
Phase
Early phase I
Treatment
CIN-107 2 mg dosing
One tablet of CIN-107 2 mg tablets, once daily, by mouth, for dosing at 2 mg.
Arms:
CIN-107 for dosing at 2, 4, or 8 mg (QD)
CIN-107 4 mg dosing
Two tablets of CIN-107 2 mg tablets, once daily, by mouth, for dosing at 4 mg.
Arms:
CIN-107 for dosing at 2, 4, or 8 mg (QD)
CIN-107 8 mg dosing
Four tablets of CIN-107 2 mg tablets, once daily, by mouth, for dosing at 8 mg.
Arms:
CIN-107 for dosing at 2, 4, or 8 mg (QD)
Size
15
Primary endpoint
To evaluate the safety and tolerability of CIN-107
74 Weeks
Change in mean seated systolic blood pressure (SBP)
after 12 weeks of treatment
Eligibility criteria
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 be compliant with the contraception and reproduction restrictions of the study.
5. Have increased SBP by ≥ 20 mmHg or have SBP ≥ 160 mmHg after dosing of MRA treatment is ceased for up to 4 weeks duration, or have SBP ≥ 150 mmHg for patients who are newly diagnosed with PA and have not taken an MRA in the past 12 weeks.
Exclusion Criteria:
1. At Screening Visit, have a single occurrence of mean seated SBP \> 180 mmHg or DBP \> 110 mmHg if not taking an MRA; or have a mean seated SBP ≥ 160 mmHg or DBP ≥ 100 mmHg if currently taking an MRA.
2. Have a body mass index \> 45 kg/m2.
3. Have had a previous surgical intervention for an adrenal adenoma or have a planned adrenal carcinoma, adrenalectomy, renal nerve denervation, or adrenal ablative procedure during the course of the study.
4. Have a documented estimated glomerular filtration rate \< 45 mL/min/1.73 m2.
5. Have a planned dialysis, kidney transplantation or any major surgical procedure during the course of the study.
6. Have known documented New York Heart Association class III or IV chronic heart failure.
7. Have had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before the Screening Visit.
8. Have known current severe left ventricular outflow obstruction.
9. Have had major cardiac surgery within 6 months before the Screening Visit.
10. Have a history of, or currently experiencing, clinically significant arrhythmias.
11. Have had a prior solid organ transplant or cell transplant.
12. Are positive for HIV antibody, hepatitis C virus RNA, or hepatitis B surface antigen.
13. Have typical consumption of \> 14 alcoholic drinks weekly.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 15, 'type': 'ACTUAL'}}
Updated at
2024-04-29
1 organization
1 product
2 indications
Organization
AstraZenecaProduct
CIN-107Indication
Primary AldosteronismIndication
Hyperaldosteronism