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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Kaohsiung、台湾、824
- E-DA Hospital
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Taichung、台湾、40705
- Taichung Veterans General Hospital
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Taipei、台湾、100
- National Taiwan University Hospital
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Taipei、台湾、104
- Mackay Memorial Hospital
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Taipei、台湾、114
- Tri-Service General Hospital
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Taipei、台湾、112
- Taipei Veterans General Hospital
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Taipei、台湾、112
- Cheng Hsin General Hospital
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Taoyuan County、台湾、333
- Chang Gung memorial hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:非ランダム化
- 介入モデル:階乗代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
アクティブコンパレータ:AM 5 + DM 0
Amlodipine 5 mg + DMTA07 0mg, once daily
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Amlodipine 5 mg + DMTA07 0mg, once daily
他の名前:
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実験的:AM 5 + DM 2.5
Amlodipine 5 mg + DMTA07 2.5mg, once daily
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Amlodipine 5 mg + DMTA07 0mg, once daily
他の名前:
Amlodipine 5 mg + DMTA07 2.5mg, once daily
他の名前:
|
実験的:AM 5 + DM 7.5
Amlodipine 5 mg + DMTA07 7.5mg, once daily
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Amlodipine 5 mg + DMTA07 0mg, once daily
他の名前:
Amlodipine 5 mg + DMTA07 2.5mg, once daily
他の名前:
Amlodipine 5 mg + DMTA07 7.5mg, once daily
他の名前:
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実験的:AM 5 + DM 30
Amlodipine 5 mg + DMTA07 30mg, once daily
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Amlodipine 5 mg + DMTA07 0mg, once daily
他の名前:
Amlodipine 5 mg + DMTA07 2.5mg, once daily
他の名前:
Amlodipine 5 mg + DMTA07 7.5mg, once daily
他の名前:
Amlodipine 5 mg + DMTA07 30mg, once daily
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
*SBP reduction=SBP each visit- SBPvisit2
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
The secondary objectives of the study include: Efficacy/Safety
時間枠: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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協力者と研究者
捜査官
- 主任研究者:Jaw-Wen Chen, Doctor、VGHTP
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- TSHDM1101
- DMTA07 (その他の識別子:Tshbiopharm)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
AM 5 + DM 0の臨床試験
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Rady Children's Hospital, San Diegoわからない
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Sunnybrook Health Sciences CentreKMH Cardiology and Diagnostic Centres完了