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Active Not Recruiting
NCT07352969
A Dose Finding Study of IBI3016 in Mild to Moderate Hypertensive Patients
Conditions: Hypertension
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 352
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Location: Beijing Anzhen Hospital, Capital Medical University Beijing Beijing Municipality
Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of IBI3016 or placebo, given subcutaneously, every 3 or 6 months, at different dose levels in patients with mild to moderate hypertension
Eligibility Criteria
Inclusion Criteria:
1. Signed informed consent.
2. Males or females aged 18 to 75 years.
3. Diagnosis of primary hypertension without anti-HTN medication or with one anti-HTN medication
4. Mean sitting SBP ≥140 mmHg and \< 170 mmHg measured by OBPM.
5. Participants able to understand and comply with study procedures.
Exclusion Criteria:
1. Known history of secondary hypertension.
2. Orthostatic hypotension.
3. Laboratory parameter assessments outside of range at screening:
* Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) \> 2× Upper Limit of Normal (ULN)
* Total Bilirubin \> 1.5× ULN
* International Normalized Ratio (INR) \> 2.0
* Serum Potassium \> 5 mg/L
* Estimated Glomerular Filtration Rate (eGFR) ≤ 45 mL/min/1.73m²
* QTcF \> 480 ms
4. Medical condition, other than hypertension, requiring treatment with RAAS inhibitor.
5. Current or history of intolerance to ACEi and/or ARBs.
6. Acute myocardial infarction (AMI), unstable angina, percutaneous coronary intervention (PCI) , coronary artery bypass graft (CABG), ischemic or hemorrhagic stroke, transient ischemic attack, or clinically significant cardiac arrhythmias within 6 months prior to screening. Any history of congestive heart failure.
Other protocol-defined inclusion/exclusion criteria may apply
Source: ClinicalTrials.gov (NCT07352969). StuddyBuddy aggregates publicly available trial information.