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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
Phase 2, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and pharmacodynamics of IBI3016 in patients with mild to moderate hypertension. Multiple doses of IBI3016 will be tested against placebo, administered as subcutaneous injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI3016 dose 4 | Experimental | subcutaneous injection |
|
| IBI3016 dose 1 | Experimental | subcutaneous injection |
|
| IBI3016 dose 2 | Experimental | subcutaneous injection |
|
| placebo | Placebo Comparator | subcutaneous injection |
|
| IBI3016 dose 3 | Experimental | subcutaneous injection |
|
| IBI3016 dose 5 | Experimental | subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI3016 | Drug | Solution of Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in SBP by OBPM | Change from baseline at Month 3 in systolic blood pressure (SBP) by office blood pressure measurement (OBPM) | From baseline through month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean 24hr SBP by ABPM | Change from baseline at Month 3 in mean 24hr SBP by ambulatory blood pressure measurement (ABPM) | From baseline through month 3 |
| Change in SBP and DBP by OBPM | Change from baseline through month 6 in SBP and diastolic blood pressure (DBP) by OBPM |
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Inclusion Criteria:
Exclusion Criteria:
Known history of secondary hypertension.
Orthostatic hypotension.
Laboratory parameter assessments outside of range at screening:
Medical condition, other than hypertension, requiring treatment with RAAS inhibitor.
Current or history of intolerance to ACEi and/or ARBs.
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinling Fan | Contact | 0512-69566088 | jinling.fan@innoventbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University | Beijing | Beijing Municipality | 100029 | China |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Placebo | Other | 0.9% sodium chloride saline solution |
|
| From baseline through month 6 |
| Change in Mean 24hr, mean daytime, mean nighttime SBP and DBP by ABPM | From baseline through month 6 | Change from baseline through month 6 in Mean 24hr, mean daytime, mean nighttime SBP and DBP by OBPM |
| Percentage Change in AGT by blood test | Percentage Change from baseline through month 24 in Angiotensinogen (AGT) by blood test | From baseline through month 24 |