Open-Label Extension Study of Patients Previously Enrolled in Study CIN-107-124

Hypertension Clinical Trial

Official title:

An Open-Label Extension Study of Patients Previously Enrolled in Study CIN-107-124 to Evaluate the Long-Term Safety and Effectiveness of CIN-107

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05459688
• Other study ID #: CIN-107-130
• Secondary ID: D6971C00001
• Status: Completed
• Phase: Phase 2
• Start date: April 6, 2022
• Est. completion date: November 7, 2023

Study information

• Verified date: November 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 2, multicenter, open-label extension (OLE) study to evaluate the long-term safety, tolerability, and effectiveness of CIN-107 for up to 52 weeks in patients with HTN who have completed Part 1 or Part 2 of Study CIN-107-124. The study will be conducted at clinical sites that have participated in the double-blind, Phase 2 Study CIN-107-124.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: November 7, 2023
• Est. primary completion date: November 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Have completed Part 1 or Part 2 of Study CIN-107-124;

2. Have had acceptable safety and tolerability during Study CIN-107-124 as determined by the Investigator or Medical Monitor;

3. Have demonstrated =70% and =120% adherence to their single background antihypertensive agent and the CIN-107 placebo during Study CIN-107-124;

4. Agree to comply with the contraception and reproduction restrictions of the study as follows:

• Male patients must agree to abstain from sperm donation from Day 1 through 90 days after the final dose of study drug;

• Female patients of childbearing potential (ie, ovulating, pre-menopausal, and not surgically sterile) must have a documented negative serum pregnancy test at enrollment (Visit 1); and

• Female patients of childbearing potential must use a highly effective method of contraception (ie, <1% failure rate) from Day 1 through 30 days after the last administration of study drug.

5. Are able and willing to give informed consent for participation in the clinical study.

Exclusion Criteria:

1. Have met Protocol-defined stopping criteria, were withdrawn from the study, discontinued CIN-107 at the time of Visits 6 or 9, or were not compliant with the Protocol during Study CIN-107-124;

2. Have received treatment with any investigational agent for disease intervention (ie, other than study drug) during Study CIN-107-124, or since the last administration of study drug in Study CIN-107-124, or plans to participate in another clinical study within 30 days of discontinuation of study drug;

3. Have had any new, significant, or uncontrolled comorbidity since initially enrolling in Study CIN-107-124 that would increase the risk of the patient in Study CIN-107-130, as determined by the Investigator;

4. Have had a mean seated SBP =170 mmHg or DBP =105 mmHg at the end of Part 1 or Part 2 of Study CIN-107-124;

5. Have an upper arm circumference that does not meet the cuff measurement criteria for the selected BP machine at Visit 1 of Study CIN-107-130;

6. Have any uncontrolled or clinically significant laboratory abnormality that would affect safety, interpretation of study data, or the patient's participation in the study, as determined by the Investigator;

7. Have experienced a de novo or reactivated serious viral infection such as hepatitis B, hepatitis C, or HIV during Study CIN-107-124;

8. Have had any major episode of infection requiring hospitalization or treatment with intravenous antibiotics during Study CIN-107-124;

9. Have developed a malignancy (with the exception of non-serious local and resectable basal or squamous cell carcinoma of the skin) during Study CIN-107-124;

10. Have anticipated initiation of erythropoietin-stimulating agents and/or planned transfusion within 2 months after enrollment (Visit 1);

11. Are expected to receive or are receiving any of the exclusionary drugs (strong cytochrome P450 3A inducers);

12. Have known secondary causes of HTN (eg, renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, hyperparathyroidism, pheochromocytoma, Cushing's syndrome, or aortic coarctation) except obstructive sleep apnea;

13. Have been diagnosed with New York Heart Association stage III or IV chronic heart failure during Study CIN-107-124;

14. Have had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure during Study CIN-107-124;

15. Have a known current severe left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy and/or severe aortic valvular disease diagnosed from a prior echocardiogram;

16. Have a planned coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG]) or any major surgical procedure;

17. Have had a CABG or other major cardiac surgery (eg, valve replacement), peripheral arterial bypass surgery, or PCI during Study CIN-107-124;

18. Have a planned dialysis or kidney transplant during the course of this study;

19. Have a known hypersensitivity to CIN-107 or drugs of the same class, or any of its excipients;

20. Have any clinically relevant medical or surgical conditions (including unstable conditions and/or treatment with systemic immunosuppressants including corticosteroids) that, in the opinion of the Investigator, would put the patient at risk by participating in the study;

21. Are pregnant, breastfeeding, or planning to become pregnant during the study; or

22. Are considered to be unsuitable for any other reason that may either place the patient at increased risk during participation or interfere with the interpretation of the study outcomes by the Investigator, after reviewing medical and psychiatric history, physical examination, and laboratory evaluation.

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• CIN-107
2 mg of CIN-107, once a day for 52 weeks

Locations

Country	Name	City	State
United States	Research Site	Addison	Illinois
United States	Research Site	Austin	Texas
United States	Research Site	Brooklyn	New York
United States	Research Site	Brownsburg	Indiana
United States	Research Site	Carrollton	Texas
United States	Research Site	Chicago	Illinois
United States	Research Site	Clearwater	Florida
United States	Research Site	Columbus	Ohio
United States	Research Site	Dallas	Texas
United States	Research Site	Doral	Florida
United States	Research Site	Edmond	Oklahoma
United States	Research Site	Georgetown	Texas
United States	Research Site	Hialeah	Florida
United States	Research Site	Hollywood	Florida
United States	Research Site	Houston	Texas
United States	Research Site	Huntington Park	California
United States	Research Site	Lake Worth	Florida
United States	Research Site	Lampasas	Texas
United States	Research Site	Lincoln	California
United States	Research Site	Los Angeles	California
United States	Research Site	Manassas	Virginia
United States	Research Site	Miami	Florida
United States	Research Site	Miami	Florida
United States	Research Site	Morton	Illinois
United States	Research Site	New Orleans	Louisiana
United States	Research Site	Northridge	California
United States	Research Site	Oceanside	California
United States	Research Site	Olive Branch	Mississippi
United States	Research Site	Panorama City	California
United States	Research Site	Pembroke Pines	Florida
United States	Research Site	San Antonio	Texas
United States	Research Site	Saraland	Alabama
United States	Research Site	Troy	Michigan
United States	Research Site	Van Nuys	California
United States	Research Site	West Valley City	Utah
United States	Research Site	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the long-term safety and tolerability of CIN-107	Evaluate TEAEs Evaluate treatment-emergent SAEs Evaluate TEAEs of special interest Evaluate TEAEs leading to treatment premature discontinuation Evaluate treatment-emergent marked laboratory abnormalities Evaluate the change on standing SBP and diastolic BP, measured pre-dose at the clinical site, from baseline (V1) to (EOT) Evaluate vital signs, standing BP and heart rate, physical examinations, ECGs, weight, clinical lab evaluations, including standard chemistry panel, hematology, coagulation and urinalysis	up to 52 weeks
Secondary	Mean systolic blood pressure (SBP) change		over 52 weeks
Secondary	Mean diastolic blood pressure (DBP) change		over 52 weeks
Secondary	Percentage of patients achieving a seated SBP <130 mmHg		over 52 weeks
Secondary	Percentage of non-responders in Study CIN-107-124 achieving a seated SBP response <130 mmHg with CIN-107	With/without a single background antihypertensive agent and/or rescue medication and irrespective of Study CIN-107-124 dose strength	over 52 weeks
Secondary	Percentage of responders in Study CIN-107-124 maintaining a seated SBP response <130 mmHg with CIN-107	With/without a single background antihypertensive agent and/or rescue medication and irrespective of Study CIN-107-124 dose strength	over 52 weeks