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Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Oral Lixivaptan Capsules in Subject With Euvolemic Hyponatremia

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ClinicalTrials.gov Identifier: NCT00660959
Recruitment Status : Completed
First Posted : April 18, 2008
Last Update Posted : June 28, 2011
Sponsor:
Collaborators:
Cardiokine Biopharma, LLC
Biogen
Information provided by:
CardioKine Inc.

Tracking Information
First Submitted Date  ICMJE April 15, 2008
First Posted Date  ICMJE April 18, 2008
Last Update Posted Date June 28, 2011
Study Start Date  ICMJE April 2008
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2008)
Average daily area under the curve (AUC) of change from baseline in serum sodium concentrations up to 72 hrs in lixivaptan treated subjects compared to placebo [ Time Frame: 60 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00660959 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2008)
  • Change from baseline in serum sodium on Day 30 [ Time Frame: 60 days ]
  • Percentage of subjects achieving normalized serum sodium (Na+ ≥ 135 mEq/L) [ Time Frame: 60 days ]
  • Time to first normalization of serum sodium (Na+≥135 mEq/L) [ Time Frame: 60 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Oral Lixivaptan Capsules in Subject With Euvolemic Hyponatremia
Official Title  ICMJE Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Lixivaptan Capsules in Subject With Euvolemic Hyponatremia
Brief Summary The present study is designed to confirm and extend the observation from previous studies that lixivaptan therapy corrects hyponatremia, in euvolemic subject, including subjects with SIADH.
Detailed Description Phase I Phase II clinical trials have demonstrated that lixivaptan may play an important role in treating hyponatremia and the signs and symptoms of water retention associated with HF, liver cirrhosis with ascites (LCWA) and syndrome of inappropriate antidiuretic hormone (SIADH). Lixivaptan was previously evaluated in disease states characterized by hyponatremia with euvolemia (SIADH)and hyponatremia combined with fluid overload (HF, LCWA). Lixivaptan resulted in correction in hyponatremia together with a marked aquaresis in subject with volume overload. The present study is designed to confirm and extend the observation from previous studies that lixivaptan therapy corrects hyponatremia, in euvolemic subject, including subjects with SIDH.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hyponatremia With Normal Extracellular Fluid Volume
Intervention  ICMJE
  • Drug: lixivaptan
    oral capsule
  • Drug: placebo
    oral capsule
Study Arms  ICMJE
  • Experimental: Active Comparator
    lixivaptan
    Intervention: Drug: lixivaptan
  • Placebo Comparator: Placebo
    placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2011)
106
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2008)
100
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Written informed consent
  • Men or women aged 18 or older
  • Diagnosis of euvolemic hyponatremia (120 ≤ Na+<130 mEq/L)
  • Hospitalized or willing to be admitted to a monitored setting for approximately the first 48 hours of treatment

Exclusion Criteria:

  • Pregnant or breast-feeding women, or women planning to become pregnant or to breastfeed
  • Symptomatic hyponatremia (e.g., lethargy, coma, seizures, changes in mental status attributable to hyponatremia)
  • Acute or transient hyponatremia (e.g., associated with head trauma or postoperative state)
  • Hyponatremia in hypovolemic states. Hypovolemic hyponatremia is defined as the presence of clinical evidence of extracellular fluid volume depletion
  • Hyponatremia as a result of any medication that can safely be withdrawn
  • Hyponatremia due to hypothyroidism or adrenal insufficiency
  • Diagnosis of psychogenic polydipsia
  • Receiving within 7 days of enrollment, other medication for treatment of hyponatremia specifically: demeclocycline, lithium carbonate, urea, or conivaptan
  • Use of radiotherapy and chemotherapy within 2 wks of randomization
  • Likely to require, or to receive IV saline for correction of symptomatic or asymptomatic severe hyponatremia during the course of the study
  • Supine systolic arterial blood pressure of ≤ 90 mmHg
  • Serum creatinine >3.0 mg/dL
  • History of uncontrolled type 2 diabetes mellitus
  • Severe pulmonary artery hypertension: patients whose condition is expected to deteriorate with sudden shifts in fluid volumes and cardiac filling pressures
  • Established diagnosis of New York Heart Association (NYHA) class III or IV heart failure
  • History of myocardial infarction, unstable angina or evidence of active ischemia within 30 days prior to screening
  • History of cerebral vascular accident (CVA) within 60 days prior to screening
  • Established diagnosis of nephrotic syndrome
  • Advanced liver disease or documented diagnosis of cirrhosis or alcoholic hepatitis
  • Urinary tract obstruction (benign prostatic hypertrophy [BPH] allowed if non-obstructive)
  • History of alcohol abuse or illicit drug use within the past 6 months
  • Terminally ill or moribund condition with little chance of short-term survival
  • Receiving vasopressin or its analogs for treatment of any condition
  • Known allergy to any vasopressin antagonist
  • Previous participation in a lixivaptan study
  • Recipient of any investigational treatment (drug or device) within 30 days prior to baseline visit
  • Unable to take oral medications
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Germany,   India,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00660959
Other Study ID Numbers  ICMJE CK-LX3405
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cardiokine, Inc
Study Sponsor  ICMJE CardioKine Inc.
Collaborators  ICMJE
  • Cardiokine Biopharma, LLC
  • Biogen
Investigators  ICMJE Not Provided
PRS Account CardioKine Inc.
Verification Date November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP