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Study to Evaluate the Effects of Oral Administration of Lixivaptan in Patients With Congestive Heart Failure

NCT01055912 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2011-06-28

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effects of oral lixivaptan capsules in patients with congestive heart failure.

Conditions

  • Congestive Heart Failure

Interventions

DRUG

Lixivaptan

Capsule. Patients will be screened for entry into the study and will be randomized (2:1) to lixivaptan or placebo. One hundred (100) patients will be randomized to receive lixivaptan 100 mg once daily (QD) for 8 weeks. Fifty (50) placebo patients will receive matching oral placebo for 8 weeks.

DRUG

Placebo

Patients will be screened for entry into the study and will be randomized (2:1) to lixivaptan or placebo.

Sponsors & Collaborators

  • Cardiokine Biopharma, LLC

    collaborator INDUSTRY

  • CardioKine Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-09-30

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01055912 on ClinicalTrials.gov