UMIN-CTR History
Name： UMIN ID：
| Unique ID issued by UMIN | UMIN000004749 |
|---|---|
| Receipt number | R000005654 |
| Scientific Title | A study to evaluate the long-term effect of pulmonary hypertension on prognosis, activities of daily living (ADL), cardiac function and pulmonary function in patients with COPD and IPF, respectively, according to baseline severity of pulmonary hypertension and the efficacy and safety of the Tracleer (bosentan hydrate) tablet for prognosis, activities of daily living, cardiac function and pulmonary function in patients with COPD and IPF, respectively, according to baseline severity of pulmonary hypertension. |
| Date of disclosure of the study information | 2010/12/18 |
| Last modified on | 2024/01/11 15:35:58 |
| No. | Disposal | Last modified on | Item of update | |
|---|---|---|---|---|
| 1 | Insert | 2010/12/18 08:57:51 | ||
| 2 | Update | 2011/06/18 12:41:56 | Primary outcomes Primary outcomes Key secondary outcomes Key secondary outcomes |
|
| 3 | Update | 2011/06/18 12:49:38 | Address Address Address |
|
| 4 | Update | 2011/12/18 10:50:12 | Post marketing survey by drug manufacture etc., specified by Japanese law. Email1 |
|
| 5 | Update | 2011/12/22 15:47:44 | Key secondary outcomes Key secondary outcomes |
|
| 6 | Update | 2012/12/18 14:54:41 | Key inclusion criteria Key inclusion criteria |
|
| 7 | Update | 2012/12/19 13:27:22 | Public title Public title Acronym Acronym |
|
| 8 | Update | 2012/12/19 13:32:27 | Condition Condition Narrative objectives1 Narrative objectives1 |
|
| 9 | Update | 2012/12/19 13:37:51 | Interventions/Control_1 Interventions/Control_2 Interventions/Control_3 Interventions/Control_3 Interventions/Control_4 Interventions/Control_4 Interventions/Control_5 Interventions/Control_5 Interventions/Control_6 Interventions/Control_6 Key inclusion criteria Key inclusion criteria |
|
| 10 | Update | 2013/07/02 12:33:16 | Key inclusion criteria Key inclusion criteria |
|
| 11 | Update | 2013/07/02 12:41:13 | Primary outcomes Primary outcomes |
|
| 12 | Update | 2013/11/16 09:00:25 | Email |
|
| 13 | Update | 2013/11/20 17:01:17 | Randomization Randomization unit No. of arms Interventions/Control_1 Interventions/Control_1 Interventions/Control_2 Interventions/Control_2 Interventions/Control_3 Interventions/Control_3 Interventions/Control_4 Interventions/Control_4 Interventions/Control_5 Interventions/Control_5 Interventions/Control_6 Interventions/Control_6 Interventions/Control_7 Interventions/Control_7 Interventions/Control_8 Interventions/Control_8 Interventions/Control_9 Interventions/Control_9 Interventions/Control_10 Interventions/Control_10 Key inclusion criteria Key inclusion criteria Target sample size |
|
| 14 | Update | 2013/11/21 13:12:03 | Control Interventions/Control_1 Interventions/Control_1 Interventions/Control_2 Interventions/Control_2 Interventions/Control_3 Interventions/Control_3 Interventions/Control_4 Interventions/Control_4 Interventions/Control_5 Interventions/Control_5 Interventions/Control_6 Interventions/Control_6 Interventions/Control_7 Interventions/Control_7 Interventions/Control_8 Interventions/Control_8 Interventions/Control_9 Interventions/Control_9 Interventions/Control_10 Interventions/Control_10 Key inclusion criteria Key inclusion criteria Target sample size |
|
| 15 | Update | 2013/11/21 13:22:55 | Condition Condition Narrative objectives1 Narrative objectives1 Primary outcomes Key secondary outcomes Key secondary outcomes |
|
| 16 | Update | 2013/11/21 18:38:50 | Interventions/Control_1 Interventions/Control_2 Interventions/Control_3 Interventions/Control_4 Interventions/Control_5 Interventions/Control_6 Interventions/Control_7 Interventions/Control_8 Interventions/Control_9 Interventions/Control_10 |
|
| 17 | Update | 2013/11/21 18:41:52 | Condition Condition |
|
| 18 | Update | 2013/12/18 09:19:53 | Public title |
|
| 19 | Update | 2013/12/18 10:09:37 | Last follow-up date |
|
| 20 | Update | 2015/02/17 12:11:42 | Key secondary outcomes Key secondary outcomes |
|
| 21 | Update | 2015/02/17 12:15:53 | Key exclusion criteria Key exclusion criteria |
|
| 22 | Update | 2015/02/17 12:25:42 | Last follow-up date |
|
| 23 | Update | 2015/03/09 12:57:26 | Interventions/Control_1 Interventions/Control_1 Interventions/Control_2 Interventions/Control_2 Interventions/Control_3 Interventions/Control_3 Interventions/Control_4 Interventions/Control_4 Interventions/Control_7 Interventions/Control_7 Interventions/Control_8 Interventions/Control_8 Interventions/Control_9 Interventions/Control_9 Interventions/Control_10 Interventions/Control_10 |
|
| 24 | Update | 2015/03/09 13:10:24 | Public title |
|
| 25 | Update | 2015/03/10 07:56:27 | Public title Acronym |
|
| 26 | Update | 2015/03/10 07:57:39 | Acronym |
|
| 27 | Update | 2015/04/23 13:04:54 | Public title Acronym |
|
| 28 | Update | 2015/04/24 11:26:26 | Key secondary outcomes Key secondary outcomes |
|
| 29 | Update | 2015/05/09 21:09:06 | Interventions/Control_1 Interventions/Control_2 Interventions/Control_3 Interventions/Control_4 Interventions/Control_7 Interventions/Control_8 Interventions/Control_9 Interventions/Control_10 |
|
| 30 | Update | 2016/03/10 11:26:21 | Interventions/Control_2 Interventions/Control_4 Interventions/Control_8 Interventions/Control_9 Interventions/Control_10 |
|
| 31 | Update | 2016/07/06 10:31:51 | Public title Acronym |
|
| 32 | Update | 2016/07/06 10:41:59 | Name of primary person or sponsor Organization |
|
| 33 | Update | 2016/07/06 10:47:52 | Narrative objectives1 |
|
| 34 | Update | 2016/07/06 10:59:03 | Narrative objectives1 |
|
| 35 | Update | 2016/07/09 07:31:50 | Public title Acronym |
|
| 36 | Update | 2017/07/24 18:51:13 | Key inclusion criteria Key inclusion criteria |
|
| 37 | Update | 2017/09/24 21:52:10 | Public title |
|
| 38 | Update | 2017/09/28 08:35:39 | Key inclusion criteria Key inclusion criteria |
|
| 39 | Update | 2018/11/02 09:47:12 | Public title Public title Acronym Acronym |
|
| 40 | Update | 2018/11/02 10:07:42 | Condition Narrative objectives1 Narrative objectives1 Primary outcomes Primary outcomes Key secondary outcomes Key secondary outcomes |
|
| 41 | Update | 2018/11/02 20:51:59 | Public title Acronym |
|
| 42 | Update | 2018/11/02 20:57:19 | Condition Narrative objectives1 |
|
| 43 | Update | 2018/11/02 21:26:41 | No. of arms Interventions/Control_1 Interventions/Control_1 Interventions/Control_2 Interventions/Control_2 Interventions/Control_3 Interventions/Control_3 Interventions/Control_4 Interventions/Control_4 Interventions/Control_5 Interventions/Control_5 Interventions/Control_6 Interventions/Control_6 Interventions/Control_7 Interventions/Control_7 Interventions/Control_8 Interventions/Control_8 Interventions/Control_9 Interventions/Control_9 Interventions/Control_10 Interventions/Control_10 Key inclusion criteria Key inclusion criteria Key exclusion criteria Key exclusion criteria Target sample size |
|
| 44 | Update | 2018/11/02 22:46:50 | Key secondary outcomes Key secondary outcomes |
|
| 45 | Update | 2018/11/03 21:27:07 | Interventions/Control_1 Interventions/Control_2 Interventions/Control_3 Interventions/Control_4 Interventions/Control_5 Interventions/Control_6 Interventions/Control_7 Interventions/Control_8 Key inclusion criteria Key exclusion criteria |
|
| 46 | Update | 2018/11/04 09:11:18 | Key secondary outcomes |
|
| 47 | Update | 2018/11/04 15:25:33 | Narrative objectives1 |
|
| 48 | Update | 2018/11/04 15:33:18 | Primary outcomes Primary outcomes Key secondary outcomes Key secondary outcomes |
|
| 49 | Update | 2018/11/04 15:35:39 | Key secondary outcomes |
|
| 50 | Update | 2018/11/04 15:48:38 | Public title Acronym |
|
| 51 | Update | 2018/12/08 14:57:18 | Public title Acronym |
|
| 52 | Update | 2021/11/26 09:20:50 | UMIN ID1 |
|
| 53 | Update | 2021/11/26 09:30:24 | Date of IRB |
|
| 54 | Update | 2024/01/11 15:07:31 | Public title Public title Acronym Acronym Scientific Title Scientific Title:Acronym Scientific Title:Acronym |
|
| 55 | Update | 2024/01/11 15:10:02 | Condition Condition Narrative objectives1 Narrative objectives1 |
|
| 56 | Update | 2024/01/11 15:13:05 | Interventions/Control_5 Interventions/Control_5 Interventions/Control_6 Interventions/Control_6 Interventions/Control_7 Interventions/Control_7 Interventions/Control_8 Interventions/Control_8 |
|
| 57 | Update | 2024/01/11 15:26:27 | Public title Public title Acronym Acronym Scientific Title Scientific Title Scientific Title:Acronym Scientific Title:Acronym |
|
| 58 | Update | 2024/01/11 15:27:41 | Condition Condition Narrative objectives1 Narrative objectives1 |
|
| 59 | Update | 2024/01/11 15:29:58 | Interventions/Control_5 Interventions/Control_5 Interventions/Control_6 Interventions/Control_6 Interventions/Control_7 Interventions/Control_7 Interventions/Control_8 Interventions/Control_8 |
|
| 60 | Update | 2024/01/11 15:35:58 | 1st name of lead principal investigator Last name of lead principal investigator 1st name of lead principal investigator Last name of lead principal investigator Zip code Last name of contact person Last name of contact person Zip code Organization Organization Address Address Tel |
