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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05459688
Recruitment Status : Recruiting
First Posted : July 15, 2022
Last Update Posted : July 15, 2022
Sponsor:
Information provided by (Responsible Party):
CinCor Pharma, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: CIN-107 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Eligible patients from Study CIN-107-124 who elect to participate in this study will continue treatment with 2 mg CIN-107 tablets QD after enrollment, starting at Visit 1 and concluding at EOT (Visit 7)
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 6, 2022
Estimated Primary Completion Date : November 22, 2023
Estimated Study Completion Date : November 22, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental 2 mg CIN-107 tablets QD
Treatment with 2 mg CIN-107 tablets, by mouth, once per day. Starting at Visit 1 and concluding at EOT (Visit 7).
Drug: CIN-107
2 mg of CIN-107, once a day for 52 weeks




Primary Outcome Measures :
  1. Treatment-emergent adverse events (TEAEs) [ Time Frame: 1 year ]
  2. Treatment-emergent serious adverse events (SAEs) [ Time Frame: 1 year ]
  3. TEAEs of special interest [ Time Frame: 1 year ]
  4. TEAEs leading to premature discontinuation of study drug [ Time Frame: 1 year ]
  5. Change from baseline on standing systolic blood pressure (SBP) [ Time Frame: 1 year ]
  6. Change from baseline on diastolic blood pressure (DBP) [ Time Frame: 1 year ]
  7. Respiratory rate [ Time Frame: 1 year ]
  8. Heart rate [ Time Frame: 1 year ]
  9. Body temperature [ Time Frame: 1 year ]
  10. Standing blood pressure (BP) [ Time Frame: 1 year ]
  11. Electrocardiograms (ECGs) - QRS interval [ Time Frame: 1 year ]
  12. Electrocardiograms (ECGs) - Heart rate [ Time Frame: 1 year ]
  13. Electrocardiograms (ECGs) - RR interval [ Time Frame: 1 year ]
  14. Electrocardiograms (ECGs) - QT interval [ Time Frame: 1 year ]
  15. Electrocardiograms (ECGs) - QTc (QTcF) [ Time Frame: 1 year ]
  16. Body weight [ Time Frame: 1 year ]
  17. Number of participants with abnormal laboratory standard safety chemistry panel test results, if appropriate. [ Time Frame: 1 year ]
    Test: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Blood Urea Nitrogen, Chloride, Creatinine, Gamma-gluamyl Transferase, Inorganic Phosphorus, Lipase, Sodium, Total Protein, Albumin, Amylase, Bicarbonate, Calcium, Creatine Kinase, eGFR, Glucose, Lactate Dehydrogenase, Potassium, Total Bilirubin, Uric Acid

  18. Number of participants with abnormal hematology lab test results, if appropriate. [ Time Frame: 1 year ]
    Tests: Hematocrit, Hemoglobin, Platelets, Red Blood Cell Count, White Blood Cell Count and Differential

  19. Number pf participants with abnormal laboratory coagulation test results, if appropriate [ Time Frame: 1 year ]
    Test: Activated Partial Thromboplastin Time, International Normalized Ratio, Prothrombin Time tests

  20. Number pf participants with abnormal urinalysis, if appropriate [ Time Frame: 1 year ]
    Test: Bilirubin, Blood, Glucose, Ketones, Leukocyte Esterase, Microscopy, Nitrite, pH, Protein, Specific Gravity, Urobilinogen, Albumin, Aldosterone, Creatinine, Potassium, Protein, Sodium

  21. Number pf participants with abnormal laboratory electrolyte imbalance test results, if appropriate [ Time Frame: 1 year ]
    Tests: Chemistry Panel includes Sodium, Potassium, Calcium, Protein, Chloride, Bicarbonate

  22. Percentage of patients requiring down-titration of CIN-107 [ Time Frame: 1 year ]
    Down-titration of CIN-107 from the maximal dose strength of 2 mg to a lower dose strength of 1 mg or 0.5 mg

  23. Percentage of patients resuming a single background antihypertensive agent [ Time Frame: 3 months ]
  24. Percentage of patients resuming a single background antihypertensive agent [ Time Frame: 6 months ]
  25. Percentage of patients resuming a single background antihypertensive agent [ Time Frame: 9 months ]
  26. Percentage of patients resuming a single background antihypertensive agent [ Time Frame: 1 year ]
  27. Percentage of patients requiring rescue medication [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Mean systolic blood pressure (SBP) change [ Time Frame: 1 year ]
  2. Mean diastolic blood pressure (DBP) change [ Time Frame: 1 year ]
  3. Percentage of patients achieving a seated SBP <130 mmHg [ Time Frame: 1 year ]
  4. Percentage of non-responders in Study CIN-107-124 achieving a seated SBP response <130 mmHg with CIN-107 [ Time Frame: 1 year ]
    With/without a single background antihypertensive agent and/or rescue medication and irrespective of Study CIN-107-124 dose strength

  5. Percentage of responders in Study CIN-107-124 maintaining a seated SBP response <130 mmHg with CIN-107 [ Time Frame: 1 year ]
    With/without a single background antihypertensive agent and/or rescue medication and irrespective of Study CIN-107-124 dose strength



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05459688


Contacts
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Contact: Enion Hampton 6105924222 ehampton@cincor.com

Locations
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United States, California
CinCor Site 44 Recruiting
Huntington Park, California, United States, 90255
Contact: Hsia         
CinCor Site 6 Recruiting
Lincoln, California, United States, 95648
Contact: Wayne         
CinCor Site 36 Recruiting
Northridge, California, United States, 91324
Contact: Barseghian         
United States, Florida
CinCor Site 41 Recruiting
Cooper City, Florida, United States, 33024
Contact: Lewy-Alterbaum         
CinCor Site 1 Recruiting
Lake Worth, Florida, United States, 33460
Contact: Guillen         
CinCor Site 13 Recruiting
Miami, Florida, United States, 33155
Contact: Arronte         
CinCor Site 17 Recruiting
Miami, Florida, United States, 33183
Contact: Quintero         
CinCor Site 15 Recruiting
Pembroke Pines, Florida, United States, 33027
Contact: Del Prado         
United States, Illinois
CinCor Site 33 Recruiting
Addison, Illinois, United States, 60101
Contact: Kelley         
United States, Michigan
CinCor Site 22 Recruiting
Troy, Michigan, United States, 48085
Contact: Sandberg         
United States, Mississippi
CinCor Site 64 Recruiting
Olive Branch, Mississippi, United States, 38654
Contact: Huling         
United States, Oklahoma
CinCor Site 43 Recruiting
Edmond, Oklahoma, United States, 73119
Contact: Conrad         
United States, Texas
CinCor Site 55 Recruiting
Houston, Texas, United States, 77036
Contact: Vega         
CinCor Site 53 Recruiting
San Antonio, Texas, United States, 78209
Contact: Morin         
United States, Virginia
CinCor Site 2 Recruiting
Manassas, Virginia, United States, 20108
Contact: Andrawis         
Sponsors and Collaborators
CinCor Pharma, Inc.
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Responsible Party: CinCor Pharma, Inc.
ClinicalTrials.gov Identifier: NCT05459688    
Other Study ID Numbers: CIN-107-130
First Posted: July 15, 2022    Key Record Dates
Last Update Posted: July 15, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases