EUCTR2004-000452-16-ES进行中（未招募）不适用
International, Multi-Centre, Study of One year, Open Label, Titrated Oral Tolvaptan Tablet Administration in Patients with Chronic Hyponatraemia: Extension to Studies 156-02-235 and 156-03-238 to assess One-year safety. - Salt Water Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age greater than or equal to 18 years.
- •2. Ability to provide informed consent or assesnt.
- •3. Prior successful participation in a tolvaptan hyponatraemia trial with evidence of continued need or desire for therapy.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. A current medical condition where long-term treatment with an qauaretic agent may present adn undue risk to the patient.
- •2. Hyponatraemia which is acute, reversible, artifactual or due to conditions not associated with vasopressin excess or likely to repond to aquaretic therapy.
- •3. Hyponatraemia due to reversible medical condition or therapy.
- •4. Conditions associated with an independent imminent risk of morbidity and mortality.
- •5. Conditions which confound the assessment of end points.
研究者
相似试验
进行中（未招募）
不适用
International, Multi-Centre, Study of One year, Open Label, Titrated Oral Tolvaptan Tablet Administration in Patients with Chronic Hyponatraemia: Extension to Studies 156-02-235 and 156-03-238 to assess One-year safety. - Salt Water TrialOngoing hyponatraemia in euvolemic and hypervolemic statesMedDRA version: 7Level: 1.1Classification code 10021036EUCTR2004-000452-16-CZOtsuka Pharmaceutical Development & Commercialization, Inc.200
进行中（未招募）
不适用
International, Multi-Centre, Study of One year, Open Label, Titrated Oral Tolvaptan Tablet Administration in Patients with Chronic Hyponatraemia: Extension to Studies 156-02-235 and 156-03-238 to assess One-year safety. - Salt Water TrialOngoing hyponatraemia in euvolemic and hypervolemic statesMedDRA version: 7Level: 1.1Classification code 10021036EUCTR2004-000452-16-HUOtsuka Maryland Research Institute400
进行中（未招募）
不适用
International, Multicenter, Study of One-Year, Open-Label, Titrated Oral Tolvaptan Tablet Administration in Patients With Chronic Hyponatremia Extention to Studies 156-02-235 and 156-03-238 to Asses One-Year Safety.EUCTR2004-000452-16-ITOTSUKA MARYLAND RESEARCH INSTITUTE400
进行中（未招募）
不适用
A one-year multicentre, international, randomised, double-blind study with comparison of benfluorex (150 mg od to 150 mg tid) versus pioglitazone (30 mg od to 45 mg od) in combination with sulfonylurea administered orally for the treatment of type 2 diabetes.Type II DiabetesMedDRA version: 7.0Level: PTClassification code 10012613EUCTR2005-004798-60-CZI.R.I.S. Institut de Recherches Internationales Servier840
进行中（未招募）
不适用
A one-year multicentre, international, randomised, double-blind study with comparison of benfluorex (150 mg od to 150 mg tid) versus pioglitazone (30 mg od to 45 mg od) in combination with sulfonylurea administered orally for the treatment of type 2 diabetes.EUCTR2005-004798-60-DEI.R.I.S. Institut de Recherches Internationales Servier840