- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07917039
A Phase Ⅱ Clinical Trial of SYH2072 Tablets in Participants With Primary Aldosteronism
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of SYH2072 Tablets in Chinese Participants With Primary Aldosteronism
This is a multicenter, randomized, double-blind, placebo-controlled Phase II study designed to explore the efficacy and safety of SYH2072 tablets in Chinese participants with primary aldosteronism (PA) .
연구 개요
상세 설명
Participants diagnosed with primary aldosteronism will be randomly assigned to the SYH2072 group or the placebo group for a double-blind treatment period. SYH2072 (or matching placebo) will be administered once daily, with the dose up-titrated during the treatment period based on clinical response and tolerability.
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Clinical Trials Information Group NA officer
- 전화번호: 86-311-69085587
- 이메일: ctr-contact@cspc.cn
연구 장소
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Shandong
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Jinan, Shandong, 중국, 250000
- Qilu Hospital of Shandong University
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연락하다:
- 전화번호: 86-531-82169603
- 이메일: qlyygcp_ec@qiluhospital.cn
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Aged 18 years or older; male or female.
- Documented diagnosis of primary aldosteronism (PA) before screening.
- Receiving stable antihypertensive therapy.
- Willing to discontinue mineralocorticoid receptor antagonists (MRA) or potassium-sparing diuretics.
- Mean seated office systolic blood pressure (SBP) ≥140 mmHg and <180 mmHg, and mean seated office diastolic blood pressure (DBP) <110 mmHg before randomization.
- Medication compliance of background antihypertensive therapy and placebo within 80%-120% during the run-in period.
- Voluntary participation in the study, with signed informed consent form.
Exclusion Criteria:
- Night shift workers.
- Known secondary causes of hypertension other than PA.
- Hypotension.
- Known hypersensitivity or allergic constitution.
- History of adrenal surgery, renal denervation, or similar procedures.
- History of adrenal insufficiency.
- Poorly controlled blood glucose, or GLP-1 receptor agonist not maintained at a stable dose for at least 4 weeks.
- Poorly controlled thyroid disease.
- Severe cardiovascular or cerebrovascular events within 6 months before screening.
- Severe arrhythmia within 6 months before screening.
- Severe heart failure within 6 months before screening.
- Major surgery within 6 months before screening.
- Severe gastrointestinal disease or history of gastrointestinal surgery.
- Clinically significant laboratory abnormalities.
- History of malignancy within 5 years.
- History of drug abuse within 5 years.
- Female participants who are pregnant, breastfeeding, or with a positive pregnancy test.
- Use of strong CYP3A4 inhibitors or strong CYP3A4 inducers within 4 weeks before screening.
- Participation in any drug or device clinical trial within 3 months before screening.
- Regular alcohol consumption within 90 days before screening.
- Any other reason that, in the opinion of the investigator, may prevent the participant from completing the study, or any condition for which the investigator considers enrollment inappropriate.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
위약 비교기: Placebo group
Placebo |
Placebo administered orally, once daily (QD). |
|
실험적: SYH2072 group
SYH2072 Tablets |
SYH2072 tablets administered orally, once daily (QD) Placebo administered orally, once daily (QD). |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline in seated Systolic Blood Pressure (SBP) at Week 8
기간: week 8
|
To evaluate the efficacy of SYH2072 tablets in improving blood pressure in trial participants with primary aldosteronism (PA) in China. |
week 8
|
공동 작업자 및 조사자
수사관
- 연구 의자: Yuguo Chen, Medical Doctor, Qilu Hospital of Shandong University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .