A Double-blind, Placebo-controlled Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00462670
First received: April 17, 2007
Last updated: December 24, 2013
Last verified: December 2013
  Purpose

To evaluate the efficacy and safety of 7-day repeated oral administration of OPC-41061 15 mg or placebo in congestive heart failure (CHF) patients with extracellular volume expansion despite the use of a conventional diuretic.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Body Weight (Amount of Change) [ Time Frame: baseline, Day 7 or at the time of final trial drug administration ] [ Designated as safety issue: No ]
    Change in body weight from baseline at the time of final trial drug administration


Secondary Outcome Measures:
  • Body Weight (Percent Change) [ Time Frame: baseline, Day 7 or at the time of final trial drug administration ] [ Designated as safety issue: No ]
    Percent change in body weight from baseline at the time of final trial drug administration


Enrollment: 110
Study Start Date: April 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
0mg
Drug: OPC-41061(Tolvaptan)
0, 15mg of OPC-41061 per day for 7days p.o. administration
Experimental: 2
15mg OPC-41061
Drug: OPC-41061(Tolvaptan)
0, 15mg of OPC-41061 per day for 7days p.o. administration

  Eligibility

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

Inclusion Criteria:

  1. Subjects receiving one of the following diuretic treatments (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)
  2. CHF patients with lower limb edema, jugular venous distention, or pulmonary congestion due to extracellular volume expansion Patients with pulmonary congestion can be enrolled if pulmonary congestion is confirmed on chest x-ray taken within 14 days prior to the screening examination.
  3. Male or female subjects age 20 or older and younger than 85 (at time of informed consent)
  4. Subjects who are able to stay at the study site from the day before the start of the run-in observation period until completion of postdosing examination 2 (7 to 10 days after final study drug administration)
  5. Subjects capable of giving informed consent to participate in the study of their own free will

Exclusion Criteria:

  1. Subjects with acute heart failure
  2. Subjects with an assisted circulation device
  3. Subjects 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. Subjects who develop acute myocardial infarction within 30 days prior to the screening examination
  5. Subjects with a definite diagnosis of active myocarditis or amyloid cardiomyopathy
  6. Subjects with any of the following complications or symptoms: (1)Diabetes mellitus with poorly controlled blood glucose, (2)Anuria, (3)Urination impaired due to urinary tract stricture, urinary calculus, tumor in urinary tract, or other cause
  7. Subjects with a history of any of the following diseases: (1)Sustained ventricular tachycardia or ventricular fibrillation within 30 days prior to the screening examination in patients without an implanted defibrillator, (2)Cerebrovascular disorder within 6 months prior to the screening examination (other than asymptomatic cerebral infarction), (3)Hypersensitivity or idiosyncratic reaction to benzazepine derivatives such as mozavaptan hydrochloride or benazepril hydrochloride.
  8. Subjects who are obese [body mass index (BMI, body weight (kg)/height (m)2 exceeding 35]
  9. Patients with supine systolic blood pressure exceeding 90 mmHg
  10. Subjects with any of following abnormal laboratory values: (1)Total bilirubin exceeding 3.0 mg/dL, (2)serum creatinine exceeding 3.0 mg/dL, (3)serum sodium exceeding 147 mEq/L, (4)serum potassium exceeding 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
  13. Subjects who received any investigational drug other than OPC-41061 within 30 days prior to the screening examination
  14. Subjects who previously participated in this or any other study of OPC-41061 and received OPC-41061
  15. 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: NCT00462670

Locations
Japan
Chubu region, Japan
Chugoku region, Japan
Hokkaido region, Japan
Kanto region, Japan
Kinki region, Japan
Kyushu region, Japan
Shikoku region, Japan
Tohoku 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: NCT00462670     History of Changes
Other Study ID Numbers: 156-06-002
Study First Received: April 17, 2007
Results First Received: October 31, 2013
Last Updated: December 24, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
Cardiac edema
OPC-41061
Vasopressin antagonist

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

ClinicalTrials.gov processed this record on July 22, 2014