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治験 NCT00494715 (VALID)（対象：糖尿病）は完了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
Preventing ESRD in Overt Nephropathy of Type 2 Diabetes (VALID) 第III相・フェーズ3 102 無作為化 併用療法
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT00494715 (VALID) は 治療 の研究で、糖尿病 を対象とした 第III相・フェーズ3 介入研究 臨床試験 でした。現在は 完了 です。2007年5月1日 に開始し、102 名の参加者 が参加しました。この試験は Mario Negri Institute for Pharmacological Research によって主導され、2016年4月1日 に完了しました。ClinicalTrials.gov からの最新更新日は 2016年6月1日 です。
概要
Nephropathy of type 2 diabetes is the leading cause of end stage renal disease (ESRD) world-wide and is associated with a dramatic excess cardiovascular morbidity and mortality. Two randomized trials found that angiotensin II receptor blockers (ARBs) reduce the incidence of ESRD by about 30%, but have no appreciable effects on cardiovascular mortality. Available data suggest that ACE inhibitors might be similarly ren...もっと見る
詳細説明
Introduction Nephropathy of type 2 diabetes is the leading cause of end stage renal disease (ESRD). Currently, more than 50% of patients on renal replacement therapy in the US are diabetics. The yearly incidence of diabetics progressing to ESRD and the proportion of ESRD patients with diabetes is progressively increasing due to the progressively increasing prevalence of type 2 diabetes worldwide.
Two large, multinat...
もっと見る公式タイトル
A Prospective, Randomized, Probe Trial to Evaluate Whether,at Comparable Blood Pressure Control,Combined Therapy With ACEI BEN and ARB VAL Reduces Progression to ESRD More Effectively Than BEN or VAL Alone in High Risk Patients With Type 2 Diabetes and Overt Nephropathy
疾患名
糖尿病刊行物
この臨床試験について発表された科学記事と研究論文：その他の研究識別子
- VALID
- 2006-005951-14 (EudraCT番号)
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Benazepril | Benazepril Patients satisfying the inclusion/exclusion criteria will be randomly given equivalent doses (half the standard doses recommended by the manufacturer for blood pressure control) of benazepril (10 mg/day) or valsartan (160 mg/day) or one fourth of the standard doses of both agents in combination (benazepril 5 mg/day and valsartan 80 mg/day).If well tolerated, treatment will be up-titrated to full dose of benazepril (2...もっと見る |
実験的valsartan | Valsartan Patients satisfying the inclusion/exclusion criteria will be randomly given equivalent doses (half the standard doses recommended by the manufacturer for blood pressure control) of benazepril (10 mg/day) or valsartan (160 mg/day) or one fourth of the standard doses of both agents in combination (benazepril 5 mg/day and valsartan 80 mg/day).If well tolerated, treatment will be up-titrated to full dose of benazepril (2...もっと見る |
実験的benazepril/valsartan | Benazepril/Valsartan Patients satisfying the inclusion/exclusion criteria will be randomly given equivalent doses (half the standard doses recommended by the manufacturer for blood pressure control) of benazepril (10 mg/day) or valsartan (160 mg/day) or one fourth of the standard doses of both agents in combination (benazepril 5 mg/day and valsartan 80 mg/day).If well tolerated, treatment will be up-titrated to full dose of benazepril (2...もっと見る |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Progression to ESRD (i.e. need for renal replacement therapy by chronic dialysis or renal transplantation) | 4 times a year |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Doubling of serum creatinine (versus baseline), Rate of GFR decline, Incidence of fatal and non-fatal cardiovascular events (stroke, acute myocardial infarction, sudden death), Albumin to creatinine ratio and 24-hour urinary protein excretion. | 4 times a year |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
40 Years
対象性別
全て
- Males and females >40 years old;
- High-risk subjects with type 2 diabetes (WHO criteria);
- Serum creatinine concentration of 1.8 mg/dl or more (but less than 3.5 mg/dl);
- Urinary albumin to creatinine ratio >1000mg/g for the patients without previous ACE inhibitor and ARB therapy and >500mg/g for the patients with previous ACE inhibitor or ARB therapy (in spot morning urine)
- Legal capacity;
- Written informed consent.
- Specific contraindications or history of hypersensitivity to the study drugs or other;
- Serum potassium ≥ 6 mEq/L despite diuretic therapy, and optimized metabolic and acid/base control;
- Bilateral renal artery stenosis;
- Previous history of allergy or intolerance, or evidence of immunologically-mediated renal disease, systemic diseases, cancer;
- Drug or alcohol abuse;
- Any chronic clinical conditions that may affect completion of the trial or confound data interpretation;
- Pregnancy or lactating;
- Women of childbearing potential without following a scientifically accepted form of contraception;
- Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequence of the trial;
- Evidence of an uncooperative attitude;
- Any evidence that patient will not be able to complete the trial follow-up;
- Dual RAS blockade with an ACE inhibitor and an ARB.
Mario Negri Institute for Pharmacological ResearchAgenzia Italiana del Farmaco連絡先情報がありません。
15 2カ国の場所
Bergamo
Hospital "Azienda Ospedaliera Ospedali Riuniti di Bergamo" - Unit of Diabetology, Bergamo, Bergamo, Italy
Clinical Research Center for Rare Diseases "Aldo e Cele Daccò", Ranica, Bergamo, Italy
Hospital "Bolognini", Seriate, Bergamo, Italy
Catania
Hospital "S.Marta e S.Venera", Acireale, Catania, Italy
Hospital "Vittorio Emanuele-Ferrarotto-Santo Bambino", Catania, Catania, Italy
Foggia
Hospital " Casa Sollievo della Sofferenza" - Unit of Nephrology, San Giovanni Rotondo, Foggia, Italy
Napoli
University "Federico II", Naples, Napoli, Italy
Teramo
Hospital "G:Mazzini", Teramo, Teramo, Italy
IRCCS San Raffaele - Unit of General Medicine, Milan, Italy
Hospital "Azienda Ospedaliera di Parma" - Unit of Nephrology, Parma, Italy
Hospital "Azienda Ospedaliera di Treviglio e Caravaggio" - Ambulatory of Ponte San Pietro, Ponte San Pietro, Italy
Hospital "Azienda Ospedaliera di Treviglio e Caravaggio" Unit of Diabetology and Metabolic Diseases, Romano di Lombardia, Italy
University - AUSL 1 - Institute of Medical Pathology, Sassari, Italy
Hospital "Azienda Ospedaliera di Treviglio-Caravaggio"Unit of Diabetology and Metabolic Diseases, Treviglio, Italy
Clinical Department of Endocrinology, Diabetes and Metabolic Diseases University Medical Centre Ljubljana, Ljubljana, 1000, Slovenia