Open-Label Extension Study of Patients Previously Enrolled in Study CIN-107-124
Study Details
Study Description
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 |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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
|
Outcome Measures
Primary Outcome Measures
- Treatment-emergent adverse events (TEAEs) [1 year]
- Treatment-emergent serious adverse events (SAEs) [1 year]
- TEAEs of special interest [1 year]
- TEAEs leading to premature discontinuation of study drug [1 year]
- Change from baseline on standing systolic blood pressure (SBP) [1 year]
- Change from baseline on diastolic blood pressure (DBP) [1 year]
- Respiratory rate [1 year]
- Heart rate [1 year]
- Body temperature [1 year]
- Standing blood pressure (BP) [1 year]
- Electrocardiograms (ECGs) - QRS interval [1 year]
- Electrocardiograms (ECGs) - Heart rate [1 year]
- Electrocardiograms (ECGs) - RR interval [1 year]
- Electrocardiograms (ECGs) - QT interval [1 year]
- Electrocardiograms (ECGs) - QTc (QTcF) [1 year]
- Body weight [1 year]
- Number of participants with abnormal laboratory standard safety chemistry panel test results, if appropriate. [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
- Number of participants with abnormal hematology lab test results, if appropriate. [1 year]
Tests: Hematocrit, Hemoglobin, Platelets, Red Blood Cell Count, White Blood Cell Count and Differential
- Number pf participants with abnormal laboratory coagulation test results, if appropriate [1 year]
Test: Activated Partial Thromboplastin Time, International Normalized Ratio, Prothrombin Time tests
- Number pf participants with abnormal urinalysis, if appropriate [1 year]
Test: Bilirubin, Blood, Glucose, Ketones, Leukocyte Esterase, Microscopy, Nitrite, pH, Protein, Specific Gravity, Urobilinogen, Albumin, Aldosterone, Creatinine, Potassium, Protein, Sodium
- Number pf participants with abnormal laboratory electrolyte imbalance test results, if appropriate [1 year]
Tests: Chemistry Panel includes Sodium, Potassium, Calcium, Protein, Chloride, Bicarbonate
- Percentage of patients requiring down-titration of CIN-107 [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
- Percentage of patients resuming a single background antihypertensive agent [3 months]
- Percentage of patients resuming a single background antihypertensive agent [6 months]
- Percentage of patients resuming a single background antihypertensive agent [9 months]
- Percentage of patients resuming a single background antihypertensive agent [1 year]
- Percentage of patients requiring rescue medication [1 year]
Secondary Outcome Measures
- Mean systolic blood pressure (SBP) change [1 year]
- Mean diastolic blood pressure (DBP) change [1 year]
- Percentage of patients achieving a seated SBP <130 mmHg [1 year]
- Percentage of non-responders in Study CIN-107-124 achieving a seated SBP response <130 mmHg with CIN-107 [1 year]
With/without a single background antihypertensive agent and/or rescue medication and irrespective of Study CIN-107-124 dose strength
- Percentage of responders in Study CIN-107-124 maintaining a seated SBP response <130 mmHg with CIN-107 [1 year]
With/without a single background antihypertensive agent and/or rescue medication and irrespective of Study CIN-107-124 dose strength
Eligibility Criteria
Criteria
Inclusion Criteria:
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Have completed Part 1 or Part 2 of Study CIN-107-124;
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Have had acceptable safety and tolerability during Study CIN-107-124 as determined by the Investigator or Medical Monitor;
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Have demonstrated ≥70% and ≤120% adherence to their single background antihypertensive agent and the CIN-107 placebo during Study CIN-107-124;
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Agree to comply with the contraception and reproduction restrictions of the study as follows:
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Male patients must agree to abstain from sperm donation from Day 1 through 90 days after the final dose of study drug;
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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
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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.
- Are able and willing to give informed consent for participation in the clinical study.
Exclusion Criteria:
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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;
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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;
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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;
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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;
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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;
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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;
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Have experienced a de novo or reactivated serious viral infection such as hepatitis B, hepatitis C, or HIV during Study CIN-107-124;
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Have had any major episode of infection requiring hospitalization or treatment with intravenous antibiotics during Study CIN-107-124;
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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;
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Have anticipated initiation of erythropoietin-stimulating agents and/or planned transfusion within 2 months after enrollment (Visit 1);
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Are expected to receive or are receiving any of the exclusionary drugs (strong cytochrome P450 3A inducers);
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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;
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Have been diagnosed with New York Heart Association stage III or IV chronic heart failure during Study CIN-107-124;
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Have had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure during Study CIN-107-124;
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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;
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Have a planned coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG]) or any major surgical procedure;
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Have had a CABG or other major cardiac surgery (eg, valve replacement), peripheral arterial bypass surgery, or PCI during Study CIN-107-124;
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Have a planned dialysis or kidney transplant during the course of this study;
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Have a known hypersensitivity to CIN-107 or drugs of the same class, or any of its excipients;
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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;
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Are pregnant, breastfeeding, or planning to become pregnant during the study; or
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | CinCor Site 44 | Huntington Park | California | United States | 90255 |
2 | CinCor Site 6 | Lincoln | California | United States | 95648 |
3 | CinCor Site 36 | Northridge | California | United States | 91324 |
4 | CinCor Site 41 | Cooper City | Florida | United States | 33024 |
5 | CinCor Site 1 | Lake Worth | Florida | United States | 33460 |
6 | CinCor Site 13 | Miami | Florida | United States | 33155 |
7 | CinCor Site 17 | Miami | Florida | United States | 33183 |
8 | CinCor Site 15 | Pembroke Pines | Florida | United States | 33027 |
9 | CinCor Site 33 | Addison | Illinois | United States | 60101 |
10 | CinCor Site 22 | Troy | Michigan | United States | 48085 |
11 | CinCor Site 64 | Olive Branch | Mississippi | United States | 38654 |
12 | CinCor Site 43 | Edmond | Oklahoma | United States | 73119 |
13 | CinCor Site 55 | Houston | Texas | United States | 77036 |
14 | CinCor Site 53 | San Antonio | Texas | United States | 78209 |
15 | CinCor Site 2 | Manassas | Virginia | United States | 20108 |
Sponsors and Collaborators
- CinCor Pharma, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIN-107-130