- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01614366
DMTA07 Combine With Amlodipine Treatment in Patients With Hypertension
A Phase II Study to Explore the Effect of Different Dose of DMTA07 Combine With Amlodipine Treatment in Patients With Hypertension
연구 개요
상세 설명
To compare the different dose of DM combine with amlodipine in the treatment of mild to moderate essential hypertension, and to define the optimized dose of DM in the combination therapy.
The purpose of this study is to compare the antihypertensive efficacy and tolerability of different dose of DM combines with amlodipine treatment, further to explore the optimized combination dose of DM.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Kaohsiung, 대만, 824
- E-DA Hospital
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Taichung, 대만, 40705
- Taichung Veterans General Hospital
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Taipei, 대만, 100
- National Taiwan University Hospital
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Taipei, 대만, 104
- Mackay Memorial Hospital
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Taipei, 대만, 114
- Tri-Service General Hospital
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Taipei, 대만, 112
- Taipei Veterans General Hospital
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Taipei, 대만, 112
- Cheng Hsin General Hospital
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Taoyuan County, 대만, 333
- Chang Gung memorial hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Male or female patient aged between 50 to 75 years old (both included);
Patient with mild to moderate essential hypertension at enrollment, which defined as the following:
Patient must have mean sitting SBP ≥140 and <180 mmHg or mean sitting DBP ≥90 and <110 mmHg at enrollment;
- Patient with normal serum potassium;
- Patient or his/her legally acceptance representative has signed the written informed consent form.
Exclusion Criteria:
- Patient with severe hypertension (mean sitting DBP ≥ 110 mmHg or mean sitting SBP ≥ 180 mmHg);
- Patient with secondary hypertension, such as coarctation of aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc;
- Patient is under treatment with beta-blocker prior to enrollment;
- A definite diagnosis or unstable of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, arrhythmia and heart failure within 3 months before signing the written informed consent form;
- Patient with concomitant endocrine diseases or type 1 Diabetes Mellitus;
- Patient with type 2 Diabetes Mellitus with poor glucose control (glycosylated hemoglobin > 9% or fasting blood sugar > 250 mg/dL at enrollment) or under insulin treatment;
- Patient with clinically unstable disease such as known collagen or auto-immune disease or other malignant disease requiring current medication;
- Patient with bilateral renal artery stenosis, solitary kidney or post renal transplant;
- Patient with clinically relevant hematological disease;
Hepatic or renal dysfunction as defined by the following parameters:
- ALT or AST > 2 times upper limit of normal,
- Total bilirubin > 2 times upper limit of normal,
- Serum creatinine >2.0 mg/dl;
- Female patient who is pregnant or lactating;
- Patient with substance abuse (including alcohol) history for the past two years;
- Known or suspected contraindications, including allergy to DMTA07 or calcium channel blockers;
- Patient received other investigational drug or device within 30 days before signing the written informed consent form;
- Patient with any other serious disease considered by the investigator(s) not in the condition to enter the trial.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 요인 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: AM 5 + DM 0
Amlodipine 5 mg + DMTA07 0mg, once daily
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Amlodipine 5 mg + DMTA07 0mg, once daily
다른 이름들:
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실험적: AM 5 + DM 2.5
Amlodipine 5 mg + DMTA07 2.5mg, once daily
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Amlodipine 5 mg + DMTA07 0mg, once daily
다른 이름들:
Amlodipine 5 mg + DMTA07 2.5mg, once daily
다른 이름들:
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실험적: AM 5 + DM 7.5
Amlodipine 5 mg + DMTA07 7.5mg, once daily
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Amlodipine 5 mg + DMTA07 0mg, once daily
다른 이름들:
Amlodipine 5 mg + DMTA07 2.5mg, once daily
다른 이름들:
Amlodipine 5 mg + DMTA07 7.5mg, once daily
다른 이름들:
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실험적: AM 5 + DM 30
Amlodipine 5 mg + DMTA07 30mg, once daily
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Amlodipine 5 mg + DMTA07 0mg, once daily
다른 이름들:
Amlodipine 5 mg + DMTA07 2.5mg, once daily
다른 이름들:
Amlodipine 5 mg + DMTA07 7.5mg, once daily
다른 이름들:
Amlodipine 5 mg + DMTA07 30mg, once daily
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
*SBP reduction=SBP each visit- SBPvisit2
기간: 14 weeks
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The primary objective of this study is to compare the sitting systolic blood pressure (mmHg) reduction* between four dose regimens, the baseline is defined as the actual SBP value after 2 weeks of amlodipine run-in period
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14 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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The secondary objectives of the study include: Efficacy/Safety
기간: 14 weeks
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Efficacy: To compare the sitting diastolic blood pressure (mmHg) reduction* between four dose regimens, the baseline is defined as the actual DBP value after 2 weeks of amlodipine run-in period To evaluate the percentage of SBP reduction in four treatment regimens To evaluate the changes of blood pressure (mmHg) in different clusters; such as diabetes etc. Safety: To evaluate the pulse rate changes To evaluate incidences of adverse events To evaluate the change of laboratory test results from baseline |
14 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jaw-Wen Chen, Doctor, VGHTP
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- TSHDM1101
- DMTA07 (기타 식별자: Tshbiopharm)
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. .
AM 5 + DM 0에 대한 임상 시험
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Rady Children's Hospital, San Diego알려지지 않은