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Completed

NCT Number: NCT03254108

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

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.

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Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kanto, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Subjects with congestive heart failure in whom lower limb edema, pulmonary congestion, and/or jugular venous distension due to volume overload is present
  • Subjects who are currently hospitalized or who are able to be hospitalized during the trial

Exclusion criteria

  • Subjects with acute heart failure
  • Subjects with a history of hypersensitivity to any of ingredients of OPC-61815 or tolvaptan
  • Subjects who are unable to sense thirst or who have difficulty with fluid intake

Treatment and study plan

OPC-61815 injection 2mg

Drug

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

Drug

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

Drug

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

Drug

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

Drug

Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo.

Primary outcomes

  1. Maximum Plasma Concentration (Cmax) of OPC-41061 on Day 1

    Time frame: Baseline, 1, 1.5, 2, 4, 6, 12 24 hours after the start of administration of investigational drug

  2. Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC24h) on Day 1

    Time frame: Baseline, 1, 1.5, 2, 4, 6, 12 24 hours after the start of administration of investigational drug

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 18, 2017
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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