Trial record 1 of 1 for:
cin-107-124
A Study of CIN-107 in Patients With Uncontrolled Hypertension (HALO)
|
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: NCT05137002 |
|
Recruitment Status :
Recruiting
First Posted : November 30, 2021
Last Update Posted : June 22, 2022
|
Sponsor:
CinCor Pharma, Inc.
Information provided by (Responsible Party):
CinCor Pharma, Inc.
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
This is a Phase 2, randomized, multicenter study to evaluate the efficacy and safety of multiple dose strengths of CIN-107 in the treatment of patients with uncontrolled hypertension.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Uncontrolled Hypertension | Drug: CIN-107 Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 212 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Dose Strengths of CIN-107 as Compared to Placebo After 8 Weeks of Treatment in Patients With Uncontrolled Hypertension |
| Actual Study Start Date : | December 7, 2021 |
| Estimated Primary Completion Date : | September 6, 2022 |
| Estimated Study Completion Date : | September 6, 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Hypertension
| Arm | Intervention/treatment |
|---|---|
|
Experimental: CIN-107 0.5 mg
Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks
|
Drug: CIN-107
CIN-107 tablets by mouth once daily |
|
Experimental: CIN-107 1 mg
Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks
|
Drug: CIN-107
CIN-107 tablets by mouth once daily |
|
Experimental: CIN-107 2 mg
Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient may remain on CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks or withdraw study participation depending on BP control
|
Drug: CIN-107
CIN-107 tablets by mouth once daily |
|
Placebo Comparator: Placebo
Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2mg) and discontinue their background antihypertensive agent(s) for 4 weeks
|
Drug: Placebo
Placebo tablets by mouth once daily |
Primary Outcome Measures :
- Change from baseline in mean seated systolic BP (SBP) [ Time Frame: 8 weeks ]
Secondary Outcome Measures :
- Change from baseline in mean seated diastolic BP (DBP) [ Time Frame: 8 weeks ]
- Change from baseline in 24-hour urine aldosterone and serum aldosterone [ Time Frame: 8 weeks ]
- Percentage of patients achieving a mean seated SBP <130 mmHg [ Time Frame: 8 weeks ]
- Change from baseline in 24-hour urine renin and serum renin [ Time Frame: 8 weeks ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Is on a stable regimen of background antihypertensive agent(s) for at least 8 weeks and would be considered a candidate for an additional antihypertensive agent at the time of screening ;
- Has a mean seated systolic blood pressure (SBP) ≥ 140 mmHG;
- Demonstrates they are able to be adherent to the study drug and their anti-hypertensive medication during a run-in period
- If taking SGLT2 inhibitor, the regimen must be stable for at least 8 weeks prior to randomization; and
- Agrees to comply with the contraception and reproduction restrictions of the study;
Exclusion Criteria:
- Has a mean seated systolic blood pressure (SBP) ≥180 mmHG;
- Has a body mass index (BMI) >50 kg/m2;
- Is using alpha or beta blockers for any primary indication other than systemic hypertension (eg, migraine headache);
- Is not willing or not able to discontinue an MRA or potassium sparing diuretic as part of an existing antihypertensive regimen;
- Has documented estimated eGFR <30 mL/min/1.73m2;
- Has known and documented New York Heart Association stage III or IV chronic heart failure;
- Has had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before screening;
- Major cardiac surgery within 6 months before Screening;
- Has chronic permanent atrial fibrillation;
- Has uncontrolled diabetes with glycosylated hemoglobin >10% at Screening;
- Has planned dialysis or kidney transplantation planned during the course of the study;
- Prior solid organ transplant and/or cell transplants;
- Sodium <130 mEq/L;
- Potassium <3.5 mEq/L;
- Potassium >5 mEq/L;
- White blood cell count >15 × E9/L or absolute neutrophil count <1 × E9/L at Screening;
- Is positive for HIV antibody, hepatitis C virus RNA, or hepatitis B surface antigen;
- Has typical consumption of ≥14 alcoholic drinks weekly;
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): NCT05137002
Contacts
| Contact: Enion Hampton | 6105924222 | ehampton@cincor.com |
Locations
Show 63 study locations
Sponsors and Collaborators
CinCor Pharma, Inc.
| Responsible Party: | CinCor Pharma, Inc. |
| ClinicalTrials.gov Identifier: | NCT05137002 |
| Other Study ID Numbers: |
CIN-107-124 |
| First Posted: | November 30, 2021 Key Record Dates |
| Last Update Posted: | June 22, 2022 |
| Last Verified: | June 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases |