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

NCT05459688 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CIN-107-130D6971C00001
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 36

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (8)

• Number of Participants With Any Treatment-emergent Adverse Events (TEAEs)

  An AE was defined as any untoward medical occurrence in a clinical investigation participants administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product. Any medical condition already present at enrollment should be recorded as medical history and not be reported as an AE unless the medical condition or signs or symptoms present at baseline changes in severity, frequency, or seriousness at any time during the study. In this case, it was be reported as an AE.

  52 weeks

• Number of Participants With Any Treatment-emergent Adverse Events of Special Interest (AESIs)

  For this study, AESIs include the following: Events of hypotension that require clinical intervention; Abnormal potassium laboratory values that require clinical intervention; and Abnormal sodium laboratory values that require clinical intervention.

  52 weeks

• Number of Participants With Any Treatment-emergent Serious Adverse Events (TESAEs)

  An AE was or adverse reaction is considered serious if, in the view of either the Investigator or Sponsor, it results in any of the following outcomes: Death, a life-threatening AE, a persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly/birth defect, or an important medical event.

  52 weeks

• Change From Baseline in Serum Potassium

  Mean change from baseline at Week 52 in serum potassium (mmol/L).

  52 weeks

• Change From Baseline in Serum Sodium

  Mean change from baseline at Week 52 in serum sodium (mmol/L).

  52 weeks

• Change From Baseline in Body Weight

  Change from baseline at 52 weeks in body weight (kg)

  52 weeks

• Change From Baseline in Temperature

  Change from baseline at 52 weeks in temperature (C)

  52 weeks

• Change From Baseline in Seated Heart Rate

  Change from baseline at 52 weeks in seated heart rate (beats/min)

  52 weeks

Secondary Outcomes (5)

• Change From Baseline in Mean Seated Systolic Blood Pressure

  52 weeks

• Change From Baseline in Mean Seated Diastolic Blood Pressure

  52 weeks

• Achieving Mean Seated Systolic Blood Pressure <130 mmHg

  52 weeks

• Non-responders in Study CIN-107-124 Achieving a Seated SBP Response <130 mmHg

  52 weeks

• Responders in Study CIN-107-124 Achieving a Seated SBP Response <130 mmHg

  52 weeks

Study Arms (1)

Experimental 2 mg CIN-107 tablets QD

EXPERIMENTAL

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

Interventions

CIN-107 DRUG

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

Experimental 2 mg CIN-107 tablets QD

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have completed Part 1 or Part 2 of Study CIN-107-124;
• Have had acceptable safety and tolerability during Study CIN-107-124 as determined by the Investigator or Medical Monitor;
• Have demonstrated ≥70% and ≤120% adherence to their single background antihypertensive agent and the CIN-107 placebo during Study CIN-107-124;
• 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.
• Are able and willing to give informed consent for participation in the clinical study.

You may not qualify if:

• 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;
• 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;
• 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;
• 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;
• 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;
• 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;
• Have experienced a de novo or reactivated serious viral infection such as hepatitis B, hepatitis C, or HIV during Study CIN-107-124;
• Have had any major episode of infection requiring hospitalization or treatment with intravenous antibiotics during Study CIN-107-124;
• 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;
• Have anticipated initiation of erythropoietin-stimulating agents and/or planned transfusion within 2 months after enrollment (Visit 1);
• 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;
• Have been diagnosed with New York Heart Association stage III or IV chronic heart failure during Study CIN-107-124;
• Have had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure during Study CIN-107-124;
• 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;
• Have a planned coronary revascularization (percutaneous coronary intervention \[PCI\] or coronary artery bypass graft \[CABG\]) or any major surgical procedure;

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (36)

Research Site

Saraland, Alabama, 36571, United States

Location

Research Site

Huntington Park, California, 90255, United States

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Lincoln, California, 95648, United States

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Los Angeles, California, 90057, United States

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Northridge, California, 91324, United States

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Oceanside, California, 92056, United States

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Panorama City, California, 91402, United States

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Van Nuys, California, 91405, United States

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Clearwater, Florida, 33765, United States

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Doral, Florida, 33166, United States

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Hialeah, Florida, 33012, United States

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Hollywood, Florida, 33024, United States

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Lake Worth, Florida, 33467, United States

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Miami, Florida, 33165, United States

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Miami, Florida, 33173, United States

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Pembroke Pines, Florida, 33027, United States

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Winter Haven, Florida, 33880, United States

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Addison, Illinois, 60101, United States

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Chicago, Illinois, 60607, United States

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Morton, Illinois, 61550, United States

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Brownsburg, Indiana, 46112, United States

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New Orleans, Louisiana, 70124, United States

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Troy, Michigan, 48085, United States

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Olive Branch, Mississippi, 38654, United States

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Brooklyn, New York, 11235, United States

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Columbus, Ohio, 43213, United States

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Edmond, Oklahoma, 73013, United States

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Austin, Texas, 78705, United States

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Carrollton, Texas, 75006, United States

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Dallas, Texas, 75234, United States

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Georgetown, Texas, 78628, United States

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Houston, Texas, 77040, United States

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Lampasas, Texas, 76550, United States

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San Antonio, Texas, 78209, United States

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West Valley City, Utah, 84120, United States

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Manassas, Virginia, 20110, United States

Location

Related Links

• redacted SAP
• redacted CSP
• redacted CSR Synopsis

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca

information.center@astrazeneca.com

1-877-240-9479

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: July 15, 2022
• Study Start: April 6, 2022
• Primary Completion: November 7, 2023
• Study Completion: November 7, 2023
• Last Updated: December 16, 2024
• Results First Posted: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

US (36)