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CIN-107 for High Blood Pressure
Phase 2
Waitlist Available
Research Sponsored by CinCor Pharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over 52 weeks
Awards & highlights
Study Summary
This trial will evaluate the long-term safety and effectiveness of CIN-107, a medication for high blood pressure, in patients who have completed an earlier trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ over 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over 52 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To evaluate the long-term safety and tolerability of CIN-107
Secondary outcome measures
Mean diastolic blood pressure (DBP) change
Mean systolic blood pressure (SBP) change
Percentage of non-responders in Study CIN-107-124 achieving a seated SBP response <130 mmHg with CIN-107
+2 moreSide effects data
From 2022 Phase 2 trial • 275 Patients • NCT045196584%
Urinary tract infection
3%
Hyperkalaemia
1%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Safety Population 0.5mg
Safety Population 1mg
Safety Population 2mg
Safety Population Placebo
Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental 2 mg CIN-107 tablets QDExperimental Treatment1 Intervention
Treatment with 2 mg CIN-107 tablets, by mouth, once per day. Starting at Visit 1 and concluding at EOT (Visit 7).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CIN-107
2020
Completed Phase 2
~820
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Who is running the clinical trial?
CinCor Pharma, Inc.Lead Sponsor
11 Previous Clinical Trials
932 Total Patients Enrolled
AstraZenecaLead Sponsor
4,287 Previous Clinical Trials
288,619,975 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Male patients must agree to abstain from sperm donation from Day 1 through 90 days after the final dose of study drug.You are planning to start taking certain medications to stimulate red blood cell production or have a planned blood transfusion within 2 months of joining the study.You are taking or are going to take certain medications that could interfere with the study drug.You have had major heart surgery or procedures during the study period.You are planning to have dialysis or a kidney transplant during the study.You are allergic to CIN-107 or similar medications.You have completed the study.Have had acceptable safety and tolerability during Study CIN-107-124 as determined by the Investigator or Medical Monitor.You have taken your prescribed high blood pressure medication regularly, between 70% and 120% of the time, during a previous study.You have consistently taken your prescribed high blood pressure medication during the previous study.You have been diagnosed with severe chronic heart failure.Women who can have babies and are not surgically unable to have babies must have a negative pregnancy test when they first join the study.Your average blood pressure is very high, with the top number (systolic) being 170 or higher, or the bottom number (diastolic) being 105 or higher.You have had a serious viral infection like hepatitis B, hepatitis C, or HIV during the study.You have a serious heart condition that blocks blood flow from the heart.You have been diagnosed with cancer, except for non-serious skin cancers that can be easily removed.You have other health conditions that could cause high blood pressure, except for obstructive sleep apnea.You had a stroke, heart attack, or were hospitalized for heart failure during Study CIN-107-124.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental 2 mg CIN-107 tablets QD
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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