A Study to Evaluate the Safety, Efficacy of SYH2053 as Monotherapy in Chinese Participants With Non-familial Hypercholesterolemia or Mixed Hyperlipidemia
Recruiting
Phase 3
Interventional Study
Non-familial Hypercholesterolemia and Mixed Hyperlipidemia
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 760 (estimated)
- Sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · Industry
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About This Trial
The purpose of this study is to evaluate the efficacy and safety of SYH2053 monotherapy in patients with primary hypercholesterolemia (non-familial) or mixed dyslipidemia . This trial plans to enroll 760 Participants.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. 、Age ≥18 years (inclusive);
2. 、Fasting serum low-density lipoprotein cholesterol (LDL-C) levels failing to meet the target criteria at screening and prior to randomization (based on local laboratory results). Any one of the following conditions satisfies the criterion(accord…
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