A Study of OPC-41061 in Subjects With Cardiac-induced Edema (Congestive Heart Failure)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00544869
First received: October 15, 2007
Last updated: December 24, 2013
Last verified: December 2013
  Purpose

To investigate the plasma drug level, efficacy, and safety of 7-day repeated oral administration of OPC-41061 at 15 mg/day (treatment period 1) and subsequent 7-day repeated administration of OPC-41061 at 15 mg/day or 30 mg/day if diuretic effect is insufficient (treatment period 2) in congestive heart failure (CHF) patients with extracellular volume expansion despite conventional diuretic therapy.


Condition Intervention Phase
Cardiac Edema
Drug: OPC-41061 (Tolvaptan)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3 Open-label, Study of OPC-41061 in Subjects With Cardiac-induced Edema (Congestive Heart Failure) — an Investigation of the Safety of Treatment Beyond 7 Days and the Effect of Dose Escalation to 30 mg

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Body Weight [ Time Frame: Baseline, Day 14 or at the time of final drug administration ] [ Designated as safety issue: No ]
    The change of body weight from baseline at final observation


Enrollment: 52
Study Start Date: October 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: OPC-41061 (Tolvaptan)
15-30mg/day,daily for 14days

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects with cardiac edema receiving diuretic treatment since 7 days prior to the commencement of study drug administration.
  2. Subjects receiving one of the following diuretic treatments since 3 days prior to the commencement of study drug administration without changing the dose or dosing regimen (including subjects scheduled to start treatment during the run-in observation period).

    • 1. A loop diuretic at a daily dosage equivalent to 40 mg or more of furosemide
    • 2. Concomitant administration of a loop diuretic and a thiazide diuretic (at any doses)
    • 3. Concomitant administration of a loop diuretic and an anti-aldosterone drug (at any doses)
  3. CHF patients with lower limb edema, jugular venous distention, or pulmonary congestion due to extracellular volume expansion.
  4. Male or female subjects between the ages of 20 and 85, inclusive (at time of informed consent)
  5. Subjects able to stay at the study site from the day before the start of the run-in observation period until completion of post-treatment observation 2 (7 to 10 days after final study drug administration)
  6. Subjects capable of giving informed consent to participate in the study of their own free will

Exclusion Criteria:

  1. Heart failure patients with markedly fluctuating symptoms
  2. Patients with an assisted circulation device
  3. Patients with any of the following complications or symptoms:

    • 1. Suspected decrease in circulatory blood flow ,
    • 2. Hypertrophic cardiomyopathy (other than dilated phase),
    • 3. Cardiac valve disease with significant heart valve stenosis,
    • 4. Hepatic coma
  4. Patients who develop acute myocardial infarction within 30 days prior to the screening examination
  5. Patients with a definite diagnosis of active myocarditis or amyloid cardiomyopathy
  6. Subjects with any of the following complications or symptoms:

    • 1. Poorly controlled diabetes melllitus,
    • 2. Anuria,
    • 3. Urination impaired due to urinary tract stricture, urinary calculus, tumor in urinary tract, or other cause
  7. Subjects with any of the following disease histories:

    • 1. Sustained ventricular tachycardia or ventricular fibrillation within 30 days prior to the screening examination in subjects without an implanted defibrillator,
    • 2. Cerebrovascular disorder within 6 months prior to the screening examination (other than asymptomatic cerebral infarction),
    • 3. A history of hypersensitivity or idiosyncratic reaction to benzazepine derivatives such as mozavaptan hydrochloride or benazepril hydrochloride.
  8. Subjects who are severely obese [body mass index (BMI, body weight (kg)/height (m)2] exceeding 35]
  9. Subjects with systolic blood pressure in the decubitus position exceeding 90 mmHg
  10. Subjects with any of the following abnormal laboratory values:

    • 1. Total bilirubin > 3.0 mg/dL,
    • 2. serum creatinine > 3.0 mg/dL,
    • 3. serum sodium > 147 mEq/L,
    • 4. serum potassium > 5.5 mEq/L
  11. Patients who are unable to take oral medication
  12. Female subjects who are pregnant, possibly pregnant, or lactating, or who plan to become pregnant during the study period
  13. Subjects who received any investigational drug other than OPC-41061 within 30 days prior to the screening examination
  14. Subjects otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00544869

Locations
Japan
Chubu region, Japan
Hokkaido region, Japan
Kanto region, Japan
Kinki region, Japan
Kyuush, Japan
Shikoku region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Katsuhisa Saito Division of New Product Evaluation and Development
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00544869     History of Changes
Other Study ID Numbers: 156-06-006
Study First Received: October 15, 2007
Results First Received: November 5, 2013
Last Updated: December 24, 2013
Health Authority: Japan:Ministry of Health,Lober and Welfare

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
Vasopressin antagonist , Cardiac Edema ,Diuretics

Additional relevant MeSH terms:
Edema
Edema, Cardiac
Heart Failure
Cardiovascular Diseases
Heart Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014