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Trials |  |
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- ||| Samtasu (tolvaptan sodium phosphate) / Otsuka
Enrollment open: Samtasu Post-marketing General Drug Use-results Survey in Patients With Volume Overload in Heart Failure. (clinicaltrials.gov) - Mar 10, 2023
P=N/A, N=1600, Recruiting, Sponsor: Otsuka Pharmaceutical Co., Ltd.
Not yet recruiting --> Recruiting
- || Samtasu (tolvaptan sodium phosphate) / Otsuka
Trial completion: OPC-61815 in Healthy Chinese Male Subjects (clinicaltrials.gov) - Feb 23, 2023
P1, N=18, Completed, Sponsor: Otsuka Beijing Research Institute
Not yet recruiting --> Recruiting Recruiting --> Completed
- |||||| Samtasu (tolvaptan sodium phosphate) / Otsuka
New trial: Samtasu Post-marketing General Drug Use-results Survey in Patients With Volume Overload in Heart Failure. (clinicaltrials.gov) - Feb 3, 2023
P=N/A, N=1600, Not yet recruiting, Sponsor: Otsuka Pharmaceutical Co., Ltd.
- | Samtasu (tolvaptan sodium phosphate) / Otsuka
Trial completion date: OPC-61815 in Healthy Chinese Male Subjects (clinicaltrials.gov) - Oct 12, 2022
P1, N=18, Recruiting, Sponsor: Otsuka Beijing Research Institute
Recruiting --> Completed Trial completion date: Sep 2022 --> Dec 2022
- | Samtasu (tolvaptan sodium phosphate) / Otsuka
Preclinical, Journal: In vitro and in vivo pharmacological profile of OPC-61815, a water-soluble phosphate ester pro-drug of tolvaptan. (Pubmed Central) - Oct 4, 2022
OPC-61815 exerted dose-dependent aquaretic action in rats and dogs and a corresponding anti-edematous action in rat edema models. These results suggest that OPC-61815, a water-soluble phosphate ester pro-drug of tolvaptan, is an effective aquaretic by converting to tolvaptan after intravenous administration.
- | Samtasu (tolvaptan sodium phosphate) / Otsuka
Journal: Efficacy and safety of intravenous OPC-61815 compared with oral tolvaptan in patients with congestive heart failure. (Pubmed Central) - Jul 9, 2022
These results suggest that OPC-61815, a water-soluble phosphate ester pro-drug of tolvaptan, is an effective aquaretic by converting to tolvaptan after intravenous administration. OPC-61815 (16-mg injection) was confirmed as non-inferior to oral tolvaptan (15-mg tablet) in patients with congestive heart failure and inadequate response to diuretics; no new safety concerns were observed.
- || Samtasu (tolvaptan sodium phosphate) / Otsuka
Enrollment open, Trial completion date, Trial primary completion date: OPC-61815 in Healthy Chinese Male Subjects (clinicaltrials.gov) - Jul 7, 2022
P1, N=18, Recruiting, Sponsor: Otsuka Beijing Research Institute
OPC-61815 (16-mg injection) was confirmed as non-inferior to oral tolvaptan (15-mg tablet) in patients with congestive heart failure and inadequate response to diuretics; no new safety concerns were observed. Not yet recruiting --> Recruiting | Trial completion date: Dec 2022 --> Sep 2022 | Trial primary completion date: Jun 2022 --> Sep 2022
- || Samtasu (tolvaptan sodium phosphate) / Otsuka
New P1 trial: OPC-61815 in Healthy Chinese Male Subjects (clinicaltrials.gov) - Jun 30, 2022
P1, N=18, Not yet recruiting, Sponsor: Otsuka Beijing Research Institute
- ||| Samtasu (tolvaptan sodium phosphate) / Otsuka
P3 data, Journal: Tolerability of the Intravenously Administered Tolvaptan Prodrug, OPC-61815, in Patients With Congestive Heart Failure Who Have Difficulty With, or Are Incapable of, Oral Intake (TRITON-HF) - A Phase III, Multicenter, Open-Label Trial. (Pubmed Central) - Jun 29, 2022
Not yet recruiting --> Recruiting | Trial completion date: Dec 2022 --> Sep 2022 | Trial primary completion date: Jun 2022 --> Sep 2022 The tolerability of once daily (up to 5 days) intravenous OPC-61815 (8 mg or 16 mg) was confirmed in patients with CHF who had difficulty with, or were incapable of, oral intake.
- || tolvaptan prodrug (OPC-61815) / Otsuka
Clinical, P2 data, PK/PD data, Journal: Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of OPC-61815, a Prodrug of Tolvaptan for Intravenous Administration, in Patients With Congestive Heart Failure - A Phase II, Multicenter, Double-Blind, Randomized, Active-Controlled Trial. (Pubmed Central) - Apr 15, 2022
The tolerability of once daily (up to 5 days) intravenous OPC-61815 (8 mg or 16 mg) was confirmed in patients with CHF who had difficulty with, or were incapable of, oral intake. In this first study of OPC-61815 in patients with CHF, exposure following a single IV administration of OPC-61815 16 mg was comparable with a single oral administration of tolvaptan 15 mg, with no safety concerns.
- || Samtasu (tolvaptan sodium phosphate) / Otsuka
Trial completion: A Phase I, Open-Label Trial to Assess the Absorption, Metabolism, and Excretion of (14C)-OPC-61815 in Healthy Male Japanese Subjects (clinicaltrials.gov) - Mar 1, 2021
P1, N=8, Completed, Sponsor: Otsuka Pharmaceutical Co., Ltd.
In this first study of OPC-61815 in patients with CHF, exposure following a single IV administration of OPC-61815 16 mg was comparable with a single oral administration of tolvaptan 15 mg, with no safety concerns. Recruiting --> Completed
- ||||||| Samtasu (tolvaptan sodium phosphate) / Otsuka
Trial completion, Trial completion date, Trial primary completion date, Head-to-Head: Efficacy and Safety Trial of OPC-61815 Injection Compared With Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure (clinicaltrials.gov) - Jan 22, 2021
P3, N=294, Completed, Sponsor: Otsuka Pharmaceutical Co., Ltd.
Recruiting --> Completed Active, not recruiting --> Completed | Trial completion date: Nov 2020 --> Jul 2020 | Trial primary completion date: Nov 2020 --> Jul 2020
- || Samtasu (tolvaptan sodium phosphate) / Otsuka
Trial completion: Safety Trial of OPC-61815 Injection in Patients With Congestive Heart Failure Who Have Difficulty With or Are Incapable of Oral Intake (clinicaltrials.gov) - Nov 18, 2020
P3, N=45, Completed, Sponsor: Otsuka Pharmaceutical Co., Ltd.
Active, not recruiting --> Completed | Trial completion date: Nov 2020 --> Jul 2020 | Trial primary completion date: Nov 2020 --> Jul 2020 Recruiting --> Completed
- ||| Samtasu (tolvaptan sodium phosphate) / Otsuka
Trial completion: Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure (clinicaltrials.gov) - Nov 13, 2020
P=N/A, N=61, Completed, Sponsor: Otsuka Pharmaceutical Co., Ltd.
Recruiting --> Completed Active, not recruiting --> Completed
- ||||| Samtasu (tolvaptan sodium phosphate) / Otsuka
Enrollment closed, Trial completion date, Trial primary completion date, Head-to-Head: Efficacy and Safety Trial of OPC-61815 Injection Compared With Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure (clinicaltrials.gov) - Nov 2, 2020
P3, N=288, Active, not recruiting, Sponsor: Otsuka Pharmaceutical Co., Ltd.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting | Trial completion date: Jul 2020 --> Nov 2020 | Trial primary completion date: Jul 2020 --> Nov 2020
- || Samtasu (tolvaptan sodium phosphate) / Otsuka
New P1 trial: A Phase I, Open-Label Trial to Assess the Absorption, Metabolism, and Excretion of (14C)-OPC-61815 in Healthy Male Japanese Subjects (clinicaltrials.gov) - Dec 1, 2019
P1, N=6, Recruiting, Sponsor: Otsuka Pharmaceutical Co., Ltd.
- || Samtasu (tolvaptan sodium phosphate) / Otsuka
Trial completion, Trial completion date, Trial primary completion date: Phase I Study of OPC-61815 (clinicaltrials.gov) - Jun 19, 2019
P1, N=48, Completed, Sponsor: Otsuka Pharmaceutical Co., Ltd.
Recruiting --> Active, not recruiting | Trial completion date: Jul 2020 --> Nov 2020 | Trial primary completion date: Jul 2020 --> Nov 2020 Active, not recruiting --> Completed | Trial completion date: Dec 2018 --> Jul 2018 | Trial primary completion date: Dec 2018 --> Jul 2018
- |||| Samtasu (tolvaptan sodium phosphate) / Otsuka
New P3 trial: Safety Trial of OPC-61815 Injection in Patients With Congestive Heart Failure Who Have Difficulty With or Are Incapable of Oral Intake (clinicaltrials.gov) - May 22, 2019
P3, N=40, Recruiting, Sponsor: Otsuka Pharmaceutical Co., Ltd.
- |||||||||| Samtasu (tolvaptan sodium phosphate) / Otsuka
New P3 trial, Head-to-Head: Efficacy and Safety Trial of OPC-61815 Injection Compared With Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure (clinicaltrials.gov) - Dec 11, 2018
P3, N=288, Recruiting, Sponsor: Otsuka Pharmaceutical Co., Ltd.
- | Samtasu (tolvaptan sodium phosphate) / Otsuka
Enrollment closed, Trial completion date, Trial primary completion date: Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure (clinicaltrials.gov) - Oct 30, 2018
P=N/A, N=61, Active, not recruiting, Sponsor: Otsuka Pharmaceutical Co., Ltd.
Active, not recruiting --> Completed | Trial completion date: Dec 2018 --> Jul 2018 | Trial primary completion date: Dec 2018 --> Jul 2018 Recruiting --> Active, not recruiting | Trial completion date: May 2018 --> Feb 2019 | Trial primary completion date: May 2018 --> Feb 2019
- | Samtasu (tolvaptan sodium phosphate) / Otsuka
Enrollment closed: Phase I Study of OPC-61815 (clinicaltrials.gov) - Oct 23, 2018
P1, N=48, Active, not recruiting, Sponsor: Otsuka Pharmaceutical Co., Ltd.
Recruiting --> Active, not recruiting | Trial completion date: May 2018 --> Feb 2019 | Trial primary completion date: May 2018 --> Feb 2019 Recruiting --> Active, not recruiting
- | Samtasu (tolvaptan sodium phosphate) / Otsuka
Trial completion date, Trial primary completion date: Phase I Study of OPC-61815 (clinicaltrials.gov) - Aug 16, 2018
P1, N=48, Recruiting, Sponsor: Otsuka Pharmaceutical Co., Ltd.
Recruiting --> Active, not recruiting Trial completion date: Jul 2018 --> Dec 2018 | Trial primary completion date: Jul 2018 --> Dec 2018
- || Samtasu (tolvaptan sodium phosphate) / Otsuka
New P1 trial: Phase I Study of OPC-61815 (clinicaltrials.gov) - Apr 26, 2018
P1, N=48, Recruiting, Sponsor: Otsuka Pharmaceutical Co., Ltd.
- ||| Samtasu (tolvaptan sodium phosphate) / Otsuka
New trial: Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure (clinicaltrials.gov) - Aug 18, 2017
P=N/A, N=55, Recruiting, Sponsor: Otsuka Pharmaceutical Co., Ltd.