A Valsartan 80 Mg-Referenced, Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan 30 mg During 24 Hours in Patients With Mild to Moderate Essential Hypertension
2014年9月5日 更新者:Boryung Pharmaceutical Co., Ltd
A Randomized, Double-blind, Valsartan 80 Mg-Referenced, Parallel Grouped, Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan 30 mg During 24 Hours in Patients With Mild to Moderate Essential Hypertension
The purpose of this study is to Evaluate the Antihypertensive efficacy of Fimasartan 30 mg during 24 hours in Patients with Mild to Moderate Essential Hypertension
調査の概要
研究の種類
介入
入学 (実際)
75
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Seoul、大韓民国、110-744
- Seoul National University Hospital
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
20年~70年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Subjects aged 20 to 70 years
- Essential hypertension subjects who are measured more 135/85 mmHg of average Diastolic Blood pressure (DBP) and Systolic Blood pressure (SBP) measured by ABP monitor at baseline visit(day 0)
- Subjects who agreed to participate in this study and submitted the written informed consent
- Subjects who considered to understand this study, be cooperative, and able to be followed-up whole of the study period
Exclusion Criteria:
- Severe hypertension patients; more 180 mmHg of mean sitting SBP and/or more 110 mmHg of mean sitting DBP measured as an office Blood pressure (BP), before Randomization (Screening visit, Placebo run-in visit, Pre-Baseline visit, Baseline visit)
- Patients with difference of office BP at selected one arm over DBP 10 mmHg and/or SBP 20 mmHg at screening visit
- Patients with secondary hypertension
- Patients with symptomatic orthostatic hypotension
- Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c > 9%, increased regimen of oral hypoglycemic agent, using insulin at baseline visit)
- Patients with severe heart disease, ischemic heart disease within 6 months, peripheral vascular disease, Percutaneous Transluminal Coronary Angiography (PTCA), Coronary Artery Bypass Graft (CABG)
- Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia
- Patients with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve disease
- Patients with severe cerebrovascular disease within 6 months
- Patients with known severe or malignancy retinopathy within 6 months
- Patients with wasting disease, autoimmune disease, connective tissue disease
- Patients with significant investigations - abnormal renal function (Creatinine more 1.5 times than upper limit of normal), abnormal liver function (Aspartate Transaminase(AST), Alanine Transaminase(ALT) more 2 times than upper normal)
- Patients with surgical or medical disease which is able to be affect to absorption, distribution, metabolism, excretion
- Patients with hereditary disorders of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Patients with significant investigations - Hypokalemia(Less than 3.5mmol/L), Hyperkalemia(exceeded 5.5mmol/L)
- Patients with depletion of body fluid or sodium ion not able to correct
- Patients with suspected or history of drug or alcohol abuse within the past two years
- Childbearing, breast-feeding women and female who plan to become pregnancy or have a possibility of pregnancy but don't prevent conception with acknowledged methods
- Patients with any chronic inflammation disease needed to chronic inflammation therapy
- Patients with hepatitis type B or type C and carriers
- Patients with laboratory test results indicating clinically significant abnormal results
- Patients receiving medication that can affect blood pressure
- Patients with history of allergic reaction to any angiotensin II antagonist
- Patients with the medical histories of malignant tumor within 5years, except local basal cell carcinoma of the skin
- Patients who took investigational drug within 12 weeks from screening visit or is going on the progress of other clinical trial
- Subject who are judged unsuitable to participate in this study by investigator
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Fimasartan 30 mg
Take one capsule filled with a Fimasartan 30 mg in the every morning
|
Fimasartan 30 mg
他の名前:
|
|
アクティブコンパレータ:Valsartan 80 mg
Take one capsule filled with a Valsartan 80 mg in the every morning
|
Valsartan 80 mg
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean Systolic Blood Pressure during 24 hours
時間枠:8 weeks from baseline visit
|
To compare the difference of Mean Systolic Blood Pressure during 24 hours at 8 weeks from baseline visit
|
8 weeks from baseline visit
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean Diastolic Blood Pressure during 24 hours
時間枠:8 weeks from baseline visit
|
To compare the difference of Mean Diastolic Blood Pressure during 24 hours at 8 weeks from baseline visit
|
8 weeks from baseline visit
|
|
Mean Diastolic Blood pressure and Systolic Blood pressure during daytime or nighttime
時間枠:8 weeks from baseline visit
|
To compare the difference of Diastolic Blood pressure and Systolic Blood pressure during daytime or nighttime at 8 weeks from baseline visit
|
8 weeks from baseline visit
|
|
Sitting Diastolic Blood pressure and Systolic Blood pressure
時間枠:8 weeks from baseline visit
|
To compare the difference of Sitting Diastolic Blood pressure and Systolic Blood pressure at 8 weeks from baseline visit
|
8 weeks from baseline visit
|
|
Trough-to-peak ratio
時間枠:8 weeks from baseline visit
|
Trough-to-peak ratio of systolic blood pressure and diastolic blood pressure measured by ABP(Ambulatory Blood Pressure) monitor
|
8 weeks from baseline visit
|
|
Smoothness index
時間枠:8 weeks from baseline visit
|
Smoothness index of systolic blood pressure and diastolic blood pressure measured by ABP monitor
|
8 weeks from baseline visit
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Adverse events
時間枠:about 10~11weeks from placebo run-in visit
|
Adverse evnt(AE)s are collected as a safety measure.
All AEs are arranged based on severity, relevance to the investigational drug and serious adverse event each.
|
about 10~11weeks from placebo run-in visit
|
|
Adverse changes in laboratory test results
時間枠:about 10~11weeks from screening visit
|
Adverse changes in laboratory test results are collected as a safety measure.
As a continuous data group for each test visit, adverse changes in laboratory test results present descriptive statistics (mean, standard deviation, minimum, maximum, etc.)
|
about 10~11weeks from screening visit
|
|
Adverse changes in electrocardiography(ECG)
時間枠:about 10~11weeks from screening visit
|
Adverse changes in ECG are collected as a safety measure.
As a categorical data, adverse changes in ECG present frequency and percentage for each category.
|
about 10~11weeks from screening visit
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
捜査官
- スタディチェア:Byung-He Oh, professor、Seoul National University Hospital
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2013年5月1日
一次修了 (実際)
2014年2月1日
研究の完了 (実際)
2014年2月1日
試験登録日
最初に提出
2013年5月31日
QC基準を満たした最初の提出物
2013年6月12日
最初の投稿 (見積もり)
2013年6月14日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年9月8日
QC基準を満たした最後の更新が送信されました
2014年9月5日
最終確認日
2014年9月1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
- A657-BR-CT-L201
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。