冠動脈疾患患者におけるニトログリセリンとヌランドシグアト併用時の安全性および身体への影響に関する研究
安定冠動脈疾患患者におけるヌランドシグアートの安全性、忍容性および薬力学効果に対する0.4 mgニトログリセリンスプレーの影響を調査するランダム化、プラセボ対照、単盲検薬物相互作用試験
This study is designed to find out how safe nitroglycerin is and how it affects the body when it is taken together with another medicine called nurandociguat in people who have coronary artery disease (CAD). CAD is a condition where the arteries that supply blood to the heart become narrowed or blocked, often causing chest pain or even heart attacks. Many people with CAD also have chronic kidney disease (CKD), a long-term condition where the kidneys do not work as well as they should.
People with CAD often use nitroglycerin to help improve blood flow to the heart. Nurandociguat is a new medicine being studied to help people with CKD by widening blood vessels and improving blood flow. Both nitroglycerin and nurandociguat work in similar ways in the body, so taking them together could have a stronger effect on blood vessels. This might lead to a sudden drop in blood pressure or other side effects. The main goal of this study is to learn how safe it is to use nitroglycerin and nurandociguat together, and to understand how they interact in the body.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：Therapeutic Area Head
- 電話番号：4930300139003
- メール：clinical-trials-contact@bayer.com
研究場所
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Berlin、ドイツ、13353
- Deutsches Herzzentrum der Charité (DHZC) - Klinik für Kardiologie, Angiologie und Intensivmedizin CVK
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Baden-Wurttemberg
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Heidelberg、Baden-Wurttemberg、ドイツ、69120
- Universitätsklinikum Heidelberg - Zentrum für Innere Medizin, Abteilung Klinische Pharmakologie und Pharmakoepidemologie
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North Rhine-Westphalia
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Bonn、North Rhine-Westphalia、ドイツ、53127
- UK Bonn Institut für Klinische Chemie und Klinische Pharmakologie, Phase I Einheit und Arzneimitteltherapiesicherheit
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Thuringia
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Erfurt、Thuringia、ドイツ、99084
- SocraTec R&D Erfurt-Clinical Pharmacology Unit
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Sofia City Province
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Sofia、Sofia City Province、ブルガリア、1000
- Comac Medical | Phase I Clinical Research Unit
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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:
- Participant must be 40 to 80 years of age inclusive at the time of signing the informed consent
- Participants with stable CAD defined by coronary artery stenosis in any of the 3 main coronary vessels greater than 50 percent documented by coronary angiography within the last 36 months or history of myocardial infarction more than 6 months prior to the screening visit
- Estimated glomerular filtration rate (eGFR) greater than or equal to 30 mL per min per 1.73 m2 at screening
- Body weight greater than or equal to 60 kg and body mass index within the range greater than or equal to 18 and less than or equal to 36 kg per m2 at screening.
Exclusion Criteria:
- Ejection fraction less than 30 percent at screening as determined by echocardiography
- Progressive angina with symptoms of worsening of angina in the 3 months prior to the first screening examination and/or interventions such as revascularization by percutaneous coronary intervention and or coronary artery bypass graft during the last 3 months
- Documented current relevant coronary stenosis greater than or equal to 90 percent in any of the main 3 coronary vessels without bypass graft
- Significant valvular heart disease with moderate or severe aortic stenosis or any other significant stenosis any other moderate or severe valvular failures hypertrophic obstructive cardiomyopathy
- Symptomatic carotid stenosis or transient ischemic attack or stroke within 3 months prior to the first screening examination or patients with stroke at more than 3 months prior to the first screening examination with significant residual neurologic involvement
- Atrial fibrillation pacemaker defibrillator atrial ventricular block II and III
- History of sustained ventricular tachycardia or ventricular fibrillation within 12 months prior first screening visit
- History of CNS diseases such as seizures neurodegenerative diseases
- Lung diseases such as COPD GOLD stage 2-4 pulmonary arterial hypertension or asthma
- Medical disorder condition or history of such that would impair the participant's ability to participate or complete the study in the opinion of the 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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Nurandociguat Arm
Participants receive nurandociguat plus 0.4 mg nitroglycerin spray |
0.4 mg sublingual spray Tablet, oral |
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プラセボコンパレーター：Placebo Arm
Participants receive placebo matching nurandociguat plus 0.4 mg nitroglycerin spray |
0.4 mg sublingual spray Tablet matching nurandociguat, oral |
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 |
|---|---|---|
|
Number of participants with treatment-emergent adverse events per treatment group
時間枠：Up to 7 days after the last treatment, for a total of up to about 7 weeks per participant
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The incidence of treatment-emergent adverse events will be summarized. |
Up to 7 days after the last treatment, for a total of up to about 7 weeks per participant
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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 (推定)
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
本研究に関する用語
その他の研究ID番号
- 22597
- 2025-522335-34-00 (Ctis)
- 2025 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access.
As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。