Observational Study to Evaluate Achieving LDL-cholesterol Target Level to Treat With Rovazet Tab. With Dyslipidemia Patients
A Multi-center, Prospective, Observational Study to Evaluate Achieving LDL-cholesterol Target Level to Treat With Rovazet Tab. With Dyslipidemia Patients
This study will be conducted under routine clinical practice. Rovazet tablets will be administered in accordance with the approved dosage and administration as part of standard clinical care for dyslipidemia. Data will be collected at up to three time points from study enrollment through Week 48: baseline, Week 24, and Week 48.
調査の概要
状態
条件
詳細な説明
This study is designed as a multicenter, prospective study to evaluate the effectiveness and safety of Rovazet tablets in patients diagnosed with dyslipidemia for whom treatment with Rovazet has been determined under routine clinical practice.
During routine clinical visits, the investigator will determine whether treatment with Rovazet tablets is appropriate for patients diagnosed with dyslipidemia. In the course of routine clinical care, the investigator will determine the dose and prescribe Rovazet tablets in accordance with the product labeling. The medication to be administered to the participant must be determined before the participant provides consent to participate in the study and without any intervention related to the study.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Yongan Jeong
- 電話番号：+82-31-5176-4673
- メール：yongan.jeong@inno-n.com
研究連絡先のバックアップ
- 名前：Nayoung Lee
- 電話番号：+82-31-5176-4675
- メール：nayoung.lee1@inno-n.com
研究場所
-
-
-
Seoul、韓国
- 募集
- HK inno.N Corporation
-
コンタクト：
- Ahrong Kim
- 電話番号：+82-31-5176-4666
- メール：ahrong.kim@inno-n.com
-
コンタクト：
- Nayoung Lee
- 電話番号：+82-31-5176-4675
- メール：nayoung.lee1@inno-n.com
-
-
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
サンプリング方法
調査対象母集団
6,713
説明
Inclusion Criteria:
- Adults aged 19 years or older who have been diagnosed with dyslipidemia.
- Patients for whom treatment with Rovazet tablets has been determined based on the investigator's medical judgment.
- Patients with LDL-C and HDL-C test results obtained within 3 months before the date of enrollment.
- Individuals who have voluntarily provided written informed consent to participate in this study.
Exclusion Criteria:
- Patients for whom Rovazet tablets are contraindicated according to the contraindications listed in the approved product labeling.
- Patients whom the investigator considers unsuitable for participation in this study for any other reason.
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
- 観測モデル：OTHER
- 時間の展望：PROSPECTIVE
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 |
|---|---|---|
|
The proportion of study participants who achieve the LDL-C treatment target at Week 24, according to the dyslipidemia treatment guidelines
時間枠：Day 1 to week 24
|
LDL-C treatment targets in the fifth edition of the Korean Society of Lipid and Atherosclerosis clinical practice guidelines |
Day 1 to week 24
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The proportion of study participants who achieve the LDL-C treatment target at Week 48, according to the dyslipidemia treatment guidelines.
時間枠：Day 1 to week 48
|
Day 1 to week 48
|
|
|
The percentage change from baseline in lipid profile parameters (TC, TG, HDL-C, and LDL-C) at Week 24.
時間枠：Day 1 to week 24
|
Percentage change (%) = [(Lipid profile parameter at Week 24 - Lipid profile parameter at baseline) / Lipid profile parameter at baseline] × 100 |
Day 1 to week 24
|
|
The percentage change from baseline in lipid profile parameters (TC, TG, HDL-C, and LDL-C) at Week 48.
時間枠：Day 1 to week 48
|
Percentage change (%) = [(Lipid profile parameter at Week 48 - Lipid profile parameter at baseline) / Lipid profile parameter at baseline] × 100 |
Day 1 to week 48
|
|
Medication adherence
時間枠：Day 1 to week 48
|
Assessed using the medication possession ratio (MPR) |
Day 1 to week 48
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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。