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Efficacy and Safety Trial of OPC-61815 Injection Compared With Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure

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ClinicalTrials.gov Identifier: NCT03772041
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Brief Summary:
To confirm the non-inferiority of OPC-61815 16-mg injection to tolvaptan 15-mg tablet using as the primary endpoint the change in body weight following 5-day intravenous administration of OPC-61815 16-mg injection or 5-day oral administration of tolvaptan 15-mg tablet to CHF patients with volume overload despite having received diuretics other than vasopressin antagonists

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Drug: OPC-61815 Drug: Tolvaptan Tab 15 MG Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-blind, Randomized, Active-controlled, Parallel-group, Non-inferiority Trial to Evaluate the Efficacy and Safety of OPC-61815 Injection Compared With Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure
Actual Study Start Date : January 16, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

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 16 mg
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
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 Tab 15 MG
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. Change from baseline in body weight [ Time Frame: Baseline, Day6 ]

Secondary Outcome Measures :
  1. Proportion of responders in Lower Limb Edema and Pulmonary Congestion [ Time Frame: Baseline, Day6 ]
  2. Change from baseline in jugular venous distension and hepatomegaly [ Time Frame: Baseline, Day6 ]
    Whether or not the subject has jugular venous distension will be documented, together with the vertical height (in centimeters, to 1 decimal place) from the sternal angle to the highest point of pulsation of the internal jugular vein if distension is observed. Whether or not the liver is palpable will be documented, together with the palpated width (distance from the costal arch on the right nipple line, to 1 decimal place in centimeters) if palpable. Jugular venous distension and hepatomegaly are measured by a ruler.

  3. Proportion of subjects who achieve resolution of pulmonary rales and third cardiac sound [ Time Frame: Baseline, Day6 ]
  4. Changes in New York Heart Association classification [ Time Frame: Baseline, Day6 ]


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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:

  • Patients who are currently on treatment with any of the following diuretics

    1. Loop diuretics equivalent to furosemide tablet or fine granules at a dose of 40 mg/day or higher
    2. Concomitant use of a loop diuretic and a thiazide diuretic (including thiazide analogs) at any dose
    3. Concomitant use of a loop diuretic and an aldosterone antagonist or potassium-sparing diuretic agent at any dose
  • Patients with congestive heart failure in whom lower limb edema, pulmonary congestion, and/or jugular venous distension due to volume overload is present
  • Patients who are currently hospitalized or who are able to be hospitalized during the trial

Exclusion Criteria:

  • Patients with acute heart failure
  • Patients who are on a ventricular assist device
  • Patients 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): NCT03772041


Contacts
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Contact: Drug Information Center +81-3-6361-7315

Locations
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Japan
Saiseikai Kumamoto Hospital Recruiting
Kumamoto, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
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Study Director: Osamu Sato Otsuka Pharmaceutical Co., Ltd.

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Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03772041     History of Changes
Other Study ID Numbers: 263-102-00003
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Tolvaptan
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs