HypertensionPhase 2NCT05459688

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

A Phase 2 study testing CIN-107 in people with Hypertension, run by AstraZeneca at 36 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Hypertension
What is being tested?: CIN-107
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 175 participants
Where: 36 sitesUnited States
Study dates: 6 Apr 2022to 7 Nov 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

Have met Protocol-defined stopping criteria, were withdrawn from the study, discontinued CIN-107 at the time of Visits 6 or 9, or were not compliant with the Protocol during Study CIN-107-124;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

Show all 22Show fewer

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);
Are expected to receive or are receiving any of the exclusionary drugs (strong cytochrome P450 3A inducers);
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;
Have had a CABG or other major cardiac surgery (eg, valve replacement), peripheral arterial bypass surgery, or PCI during Study CIN-107-124;
Have a planned dialysis or kidney transplant during the course of this study;
Have a known hypersensitivity to CIN-107 or drugs of the same class, or any of its excipients;
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;
Are pregnant, breastfeeding, or planning to become pregnant during the study; or
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.

Trial locations and contacts

36 sites in 1 country.

City, postcode or hospital

36 sites in 1 country

United States36 sites

Research Site
Addison, Illinois, 60101
Research Site
Austin, Texas, 78705
Research Site
Brooklyn, New York, 11235
Research Site
Brownsburg, Indiana, 46112
Research Site
Carrollton, Texas, 75006
Research Site
Chicago, Illinois, 60607
Research Site
Clearwater, Florida, 33765
Research Site
Columbus, Ohio, 43213
Research Site
Dallas, Texas, 75234
Research Site
Doral, Florida, 33166
Research Site
Edmond, Oklahoma, 73013
Research Site
Georgetown, Texas, 78628
Research Site
Hialeah, Florida, 33012
Research Site
Hollywood, Florida, 33024
Research Site
Houston, Texas, 77040
Research Site
Huntington Park, California, 90255
Research Site
Lake Worth, Florida, 33467
Research Site
Lampasas, Texas, 76550
Research Site
Lincoln, California, 95648
Research Site
Los Angeles, California, 90057
Research Site
Manassas, Virginia, 20110
Research Site
Miami, Florida, 33165
Research Site
Miami, Florida, 33173
Research Site
Morton, Illinois, 61550
Research Site
New Orleans, Louisiana, 70124
Research Site
Northridge, California, 91324
Research Site
Oceanside, California, 92056
Research Site
Olive Branch, Mississippi, 38654
Research Site
Panorama City, California, 91402
Research Site
Pembroke Pines, Florida, 33027
Research Site
San Antonio, Texas, 78209
Research Site
Saraland, Alabama, 36571
Research Site
Troy, Michigan, 48085
Research Site
Van Nuys, California, 91405
Research Site
West Valley City, Utah, 84120
Research Site
Winter Haven, Florida, 33880

Other trials in United States

About this study

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

Conditions: Hypertension
Being tested: CIN-107
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05459688
Study group	Role	What they receive
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). Receives: Drug: CIN-107

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 52 weeks
Change From Baseline in Serum Potassium
Mean change from baseline at Week 52 in serum potassium (mmol/L).
Measured: 52 weeks
Change From Baseline in Serum Sodium
Mean change from baseline at Week 52 in serum sodium (mmol/L).
Measured: 52 weeks
Change From Baseline in Body Weight
Change from baseline at 52 weeks in body weight (kg)
Measured: 52 weeks
Change From Baseline in Temperature
Change from baseline at 52 weeks in temperature (C)
Measured: 52 weeks
Change From Baseline in Seated Heart Rate
Change from baseline at 52 weeks in seated heart rate (beats/min)
Measured: 52 weeks

Secondary outcomes (5)

Change From Baseline in Mean Seated Systolic Blood Pressure
Mean change from baseline at Week 52 in seated systolic blood pressure (SBP)
Measured: 52 weeks
Change From Baseline in Mean Seated Diastolic Blood Pressure
Mean change from baseline at 52 weeks in mean seated diastolic blood pressure (DBP)
Measured: 52 weeks
Achieving Mean Seated Systolic Blood Pressure <130 mmHg
Number of participants achieved mean seated systolic blood pressure (SBP) <130 mmHg at 52 week
Measured: 52 weeks
Non-responders in Study CIN-107-124 Achieving a Seated SBP Response <130 mmHg
Number of non-responders (participants with seated SBP >=130 mmHg) 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.
Measured: 52 weeks
Responders in Study CIN-107-124 Achieving a Seated SBP Response <130 mmHg
Number of responders (participants with <130 mmHg) 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.
Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Apr 20227 Nov 2023

First posted15 Jul 2022
Study start6 Apr 2022
Primary completion7 Nov 2023
Study completion7 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
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)
Enrolment: 175 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05459688
Sponsor's protocol ID: CIN-107-130
Other IDs: D6971C00001
Status last verified: Dec 2024
First submitted: 17 Jun 2022
Last updated: 16 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05459688
Acronym / sponsor ID: CIN-107-130
Conditions: Hypertension
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 175 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 6 Apr 2022 (actual)
Primary completion: 7 Nov 2023 (actual)
Study completion: 7 Nov 2023 (actual)
First posted: 15 Jul 2022 (actual)
Results: Posted 16 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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)

Arm	Type	Receives
Experimental 2 mg CIN-107 tablets QD	Experimental	Drug: CIN-107Treatment with 2 mg CIN-107 tablets, by mouth, once per day. Starting at Visit 1 and concluding at EOT (Visit 7).

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (22 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CIN-1072 mg of CIN-107, once a day for 52 weeks	Drug	Experimental 2 mg CIN-107 tablets QD

Primary outcome

Number of Participants With Any Treatment-emergent Adverse Events (TEAEs)
Time frame: 52 weeks
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.
Number of Participants With Any Treatment-emergent Adverse Events of Special Interest (AESIs)
Time frame: 52 weeks
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.
Number of Participants With Any Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: 52 weeks
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.
Change From Baseline in Serum Potassium
Time frame: 52 weeks
Mean change from baseline at Week 52 in serum potassium (mmol/L).
Change From Baseline in Serum Sodium
Time frame: 52 weeks
Mean change from baseline at Week 52 in serum sodium (mmol/L).
Change From Baseline in Body Weight
Time frame: 52 weeks
Change from baseline at 52 weeks in body weight (kg)
Change From Baseline in Temperature
Time frame: 52 weeks
Change from baseline at 52 weeks in temperature (C)
Change From Baseline in Seated Heart Rate
Time frame: 52 weeks
Change from baseline at 52 weeks in seated heart rate (beats/min)

5 secondary outcomes

Change From Baseline in Mean Seated Systolic Blood Pressure
Time frame: 52 weeks
Change From Baseline in Mean Seated Diastolic Blood Pressure
Time frame: 52 weeks
Achieving Mean Seated Systolic Blood Pressure <130 mmHg
Time frame: 52 weeks
Non-responders in Study CIN-107-124 Achieving a Seated SBP Response <130 mmHg
Time frame: 52 weeks
Responders in Study CIN-107-124 Achieving a Seated SBP Response <130 mmHg
Time frame: 52 weeks

Results and safety

Results posted to the registry on 16 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
2mg CIN-107	175	146

Primary outcome: Number of Participants With Any Treatment-emergent Adverse Events (TEAEs)

Time frame: 52 weeks. Number. Unit: Participants

Measure	2mg CIN-107 n = 175
Value	73

Population analysed: Safety Population includes any participants enrolled in the study who have taken at least 1 dose of any study drug.

Primary outcome: Number of Participants With Any Treatment-emergent Adverse Events of Special Interest (AESIs)

Time frame: 52 weeks. Number. Unit: Participants

Measure	2mg CIN-107 n = 175
Value	7

Population analysed: Safety Population includes any participants enrolled in the study who have taken at least 1 dose of any study drug.

Primary outcome: Number of Participants With Any Treatment-emergent Serious Adverse Events (TESAEs)

Time frame: 52 weeks. Number. Unit: Participants

Measure	2mg CIN-107 n = 175
Value	8

Population analysed: Safety Population includes any participants enrolled in the study who have taken at least 1 dose of any study drug.

Primary outcome: Change From Baseline in Serum Potassium

Time frame: 52 weeks. Mean (Standard Deviation). Unit: mmol/L

Measure	2mg CIN-107 n = 127
Value	0.08 (0.417)

Population analysed: Safety Population includes any participants enrolled in the study who have taken at least 1 dose of any study drug. In the safety population 48 participants did not have baseline measure and/or 52 weeks measure for serum potassium.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 52 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
2mg CIN-107	8 of 175 (4.6%)	20 of 175 (11.4%)	0 of 175

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
redacted SAPLink provided by the sponsor.
redacted CSPLink provided by the sponsor.
redacted CSR SynopsisLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

36 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CIN-107 in people with Hypertension, run by AstraZeneca at 36 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) (time frame: 52 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05459688.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.