Primary Aldosteronism Clinical Trial
Official title:
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
Verified date | May 2024 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 15 |
Est. completion date | October 10, 2024 |
Est. primary completion date | October 10, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 130 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Research Site | Ann Arbor | Michigan |
United States | Research Site | Baltimore | Maryland |
United States | Research Site | Chicago | Illinois |
United States | Research Site | Cincinnati | Ohio |
United States | Research Site | Columbus | Ohio |
United States | Research Site | Dallas | Texas |
United States | Research Site | Greenbrae | California |
United States | Research Site | Rochester | Minnesota |
United States | Research Site | San Francisco | California |
United States | Research Site | West Hollywood | California |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the safety and tolerability of CIN-107 | Outcome measure is overall safety with is a composite of the following individual parameters (unit of measure in brackets):
Adverse Events [number of events]; ECGs [PR interval (msec), RR interval (msec), or QTcF interval (msec); clinically significant ECG findings that are detected during the study will be reported as adverse events]; Clinical laboratory evaluations including standard safety chemistry panel, hematology, coagulation, and urinalysis [clinically significant abnormal laboratory findings that are detected during the study will be reported as adverse events]; Vital signs [pulse, temperature, heart rate and blood pressure] and physical examination data changes noted as clinically significant abnormalities that arise during the study will be recorded as adverse events |
74 Weeks | |
Primary | Change in mean seated systolic blood pressure (SBP) | Effectiveness measured by change in mean seated SBP after 12 weeks of treatment in patients with PA | after 12 weeks of treatment | |
Secondary | Change in mean diastolic blood pressure (DBP) | Comparison of changes in mean SBP after 12 weeks of treatment in patients with PA. | after 12 weeks of treatment | |
Secondary | The percentage of patients achieving a seated blood pressure (BP) response <140/90 mmHg | The percent of patients who achieved a seated BP response <140/90 mmHg after CIN107 treatment will be evaluated at each dose level at Week 12. | at Week 12 | |
Secondary | The percentage of patients achieving a seated BP response <130/80 mmHg | The percent of patients who achieved a seated BP response <130/80 mmHg after CIN107 treatment will be evaluated at each dose level at Week 12. | at Week 12 | |
Secondary | The percentage of patients achieving either: - a plasma aldosterone concentration (PAC) < 15 ng/dL and a plasma renin activity (PRA) = 0.5 ng/mL/h; or - an ARR < 15; or - unsuppressed renin activity PRA = 1.0 ng/mL/h | after 12 weeks of treatment |
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