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

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ClinicalTrials.gov Identifier: NCT03254108
Recruitment Status : Recruiting
First Posted : August 18, 2017
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Drug: OPC-61815 injection 2mg Drug: OPC-61815 injection 4mg Drug: OPC-61815 injection 8mg Drug: OPC-61815 injection 16mg Drug: Tolvaptan tablet 15mg Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 13, 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Tolvaptan

Arm Intervention/treatment
Experimental: 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.
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.

Experimental: 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.
Drug: 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.

Experimental: 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.
Drug: 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.

Experimental: 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.
Drug: 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.

Active Comparator: 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.
Drug: 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.




Primary Outcome Measures :
  1. Cmax on Day 1 of the treatment period [ Time Frame: Baseline, 1, 1.5, 2, 4, 6, 12 24 hours after the start of administration of investigational drug ]
  2. AUC24h on Day1 of the treatment period [ Time Frame: Baseline, 1, 1.5, 2, 4, 6, 12 24 hours after the start of administration of investigational drug ]


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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03254108


Contacts
Contact: Drug Information Center +81-3-6361-7314 koidet@otsuka.jp

Locations
Japan
Recruiting
Kanto, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Hiroaki Ono Otsuka Pharmaceutical Co., Ltd.

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03254108     History of Changes
Other Study ID Numbers: 263-102-00001
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Tolvaptan
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs