Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure

Congestive Heart Failure Clinical Trial

Official title:

A Multicenter, Double-blind, Randomized, Active-controlled, Parallel-group Comparison Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03254108
• Other study ID #: 263-102-00001
• Secondary ID: JapicCTI-173676
• Status: Completed
• Phase: N/A
• Start date: November 6, 2017
• Est. completion date: April 24, 2018

Study information

• Verified date: July 2021
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The dose for intravenous administration of OPC-61815 achieving tolvaptan exposure equivalent to that for oral administration of tolvaptan 15-mg tablet will be investigated by administering OPC-61815 injection 2 to 16mg or tolvaptan 15-mg oral tablet to subjects with congestive heart failure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: April 24, 2018
• Est. primary completion date: April 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Subjects who are currently on treatment with any of the following diuretics

• Loop diuretics equivalent to furosemide tablet or fine granules at a dose of 40 mg/day or higher

• Concomitant use of a loop diuretic and a thiazide diuretic (including thiazide analogs) at any dose

• Concomitant use of a loop diuretic and an aldosterone antagonist or potassium-sparing diuretic agent at any dose

2. Subjects with congestive heart failure in whom lower limb edema, pulmonary congestion, and/or jugular venous distension due to volume overload is present

3. Subjects who are currently hospitalized or who are able to be hospitalized during the trial

Exclusion Criteria:

1. Subjects with acute heart failure

2. Subjects with a history of hypersensitivity to any of ingredients of OPC-61815 or tolvaptan

3. Subjects who are unable to sense thirst or who have difficulty with fluid intake

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Drug:
• OPC-61815 injection 2mg
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 2 mg.
• OPC-61815 injection 4mg
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 4 mg.
• OPC-61815 injection 8mg
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 8 mg.
• OPC-61815 injection 16mg
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg.
• Tolvaptan tablet 15mg
Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Plasma Concentration (Cmax) of OPC-41061 on Day 1		Baseline, 1, 1.5, 2, 4, 6, 12 24 hours after the start of administration of investigational drug
Primary	Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC24h) on Day 1		Baseline, 1, 1.5, 2, 4, 6, 12 24 hours after the start of administration of investigational drug