Efficacy, Safety and Pharmacodynamic/Pharmacokinetic Study of Fimasartan (BR-A-657•K) (Fimasartan)
Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Antihypertensive Efficacy, Safety, Tolerability, and Pharmacodynamic/Pharmacokinetic Profiles After 4 Weeks of Oral Administration of Fimasartan(BR-A-657) at 20-180mg in Patients With Essential Hypertension
Study objective:
- To evaluate the antihypertensive efficacy, safety and tolerability of the drug after the oral administration of BR-A-657•K at 20~180mg for 4 weeks to patients with essential hypertension.
- To review the pharmacokinetic profile after the multiple administration and the pharmacodynamic profile regarding the renin-angiotensin system, after the oral administration of BR-A-657•K at 20~180mg for 4 weeks to patients with essential hypertension.
- To determine the dose for the clinical study at the next phase by analyzing the relationship between the antihypertensive efficacy and pharmacokinetic • pharmacodynamic results.
調査の概要
状態
条件
詳細な説明
Fimasartan (BR-A-657-K), a selective blocker of AT1 receptor subtype, showed the rapid and potent antihypertensive effect in many hypertensive models. Phase I study, Fimasartan (BR-A-657-K) 20mg ~ 480mg single dosing with healthy subjects, demonstrated that the Fimasartan (BR-A-657-K) was very safe and well tolerated. Another phase I study, Fimasartan (BR-A-657-K) 120mg and 360mg dosing for 7 days, also showed that Fimasartan (BR-A-657-K) was safe and tolerable though one temporal adverse event was observed in high dose.
A randomized, double-blind, placebo-controlled, parallel grouped, clinical study will be conducted to evaluate the antihypertensive efficacy and tolerability and to determine adequate antihypertensive dosage of Fimasartan(BR-A-657-K) in patients with mild to moderate essential hypertension.
Approximately 60 patients will be enrolled over 12 months in Seoul National University Hospital.
After 2 weeks of placebo run-in period, all subjects will be randomized into one of the following 5 groups. Subjects will take test drug/placebo for 28 days of treatment period. If subjects take any antihypertensive medications before screening, the subjects will have 1 week of wash-out period.
Group I : Placebo, Group II : Fimasartan 20 mg, Group III: Fimasartan 60 mg, Group IV : Fimasartan 180 mg
研究の種類
入学 (実際)
段階
- フェーズ2
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:
- Adult men and women, aged 18 - 65
- Patients with mild to moderate essential hypertension: On both screening and Day -1 visit, mean sitting DBP should be ≥ 95mmHg and ≤ 114mmHg, and ΔDBP on Day -14 and Day -1 should be within 7 mmHg
- Patients who gave their consent to participate in this study and signed the written informed consent form
- Patients who have understood the study, and been judged to be cooperative and able to participate in the study until the study completion date
Exclusion Criteria:
- Women of childbearing potential who have not received the hysterectomy or men who are not willing to use birth control measures.
- Patients whose sitting DBP is < 95mmHg or ≥ 115mmHg. Patients with severe hypertension whose SBP is ≥200mmHg
- Patients with secondary hypertension
- Patients with severe renal disease, gastrointestinal disorder, hematologic disorder, liver disease, etc. that can affect the absorption, distribution, metabolism and excretion of drugs
- Patients with symptoms of orthostatic hypotension
- Patients with severe insulin dependent diabetes or uncontrolled diabetes
- Patients who suffered myocardial infarction or serious coronary arterial disease over the past 6 months or patients with clinically significant congestive heart failure or valvular heart disease
- Patients with consumption disease, autoimmune disease, or connective tissue disease
- Patients with the history of type B hepatitis or type C hepatitis
- Patients with HIV infection or hepatitis
- Patients with clinically significant abnormal laboratory test findings
- Patients on any drug treatment that might affect the blood pressure
- Patients with allergy or contraindication to angiotensin II-receptor antagonists
- Patients with current or suspected alcohol addiction or history of drug abuse
- Patients whose mean weight lies out of the range of -15% ~ +35%, based on the Modified Metropolitan Life Insurance table
- Patients who are not eligible as subjects of the study, as determined by the principal investigator or a sub-investigator
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：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：Placebo
Placebo, 3 tablets
|
プラセボ
|
|
アクティブコンパレータ：BR-A-657•K 20 mg group
Fimasartan 20 mg, 1 tablet + placebo, 2 tablets
|
Fimasartan 20 mg, 1 tablet + placebo, 2 tablets
他の名前：
|
|
アクティブコンパレータ：BR-A-657•K 60 mg group
Fimasartan 20 mg, 1 tablet + 40 mg, 1 tablet + placebo 1 tablet
|
Fimasartan 20 mg, 1 tablet + 40 mg, 1 tablet + placebo 1 tablet
他の名前：
|
|
アクティブコンパレータ：BR-A-657•K 180 mg group
Fimasartan 20 mg, 1 tablet + 80 mg, 1 tablet + 80 mg 1 tablet
|
Fimasartan 20 mg, 1 tablet + 80 mg, 1 tablet + 80 mg 1 tablet
他の名前：
|
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 |
時間枠 |
|---|---|
|
the level of sitting diastolic blood pressure reduction
時間枠：Day -1 vs Day 27
|
Day -1 vs Day 27
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
the level of sitting systolic blood pressure reduction, mean blood pressure (MBP), 24-hr day-time, night-time SBP and DBP, T/P ratio based on the 24-hr Ambulatory Blood Pressure Monitoring
時間枠：Day -1 vs Day 27
|
Day -1 vs Day 27
|
協力者と研究者
出版物と役立つリンク
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
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。
プラセボの臨床試験
-
Palacky University完了
-
Universidade Federal do ParaConselho Nacional de Desenvolvimento Científico e Tecnológico完了
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Advice Pharma Group srl積極的、募集していない肥満 | 栄養障害 | 体重 | 減量 | 食生活 | 太りすぎと肥満 | 健康行動 | ダイエット、健康 | ダイエット習慣 | ライフスタイル | 栄養、健康 | 行動障害イタリア
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University Hospital, Strasbourg, France積極的、募集していない