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International, Multicenter Study of a Twenty-eight Week, Open-label, Titrated Oral Lixivaptan Administration in Patients With Chronic Hyponatremia: Extension to Studies CK-LX3401, 3405, and 3430

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ClinicalTrials.gov Identifier: NCT01056848
Recruitment Status : Completed
First Posted : January 26, 2010
Last Update Posted : June 21, 2011
Sponsor:
Collaborators:
Cardiokine Biopharma, LLC
Biogen
Information provided by:
CardioKine Inc.

Tracking Information
First Submitted Date January 22, 2010
First Posted Date January 26, 2010
Last Update Posted Date June 21, 2011
Study Start Date January 2010
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 25, 2010)
To assess the safety of long-term lixivaptan use in patients who were previously enrolled in one of the 3 Phase III trials. [ Time Frame: 28 weeks ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01056848 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 25, 2010)
To demonstrate that after open-label lixivaptan treatment: improvements in the time to complete the TMT-B will be maintained compared to baseline, and improvements in the Medical Outcomes Survey will be maintained compared to baseline. [ Time Frame: 28 weeks ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title International, Multicenter Study of a Twenty-eight Week, Open-label, Titrated Oral Lixivaptan Administration in Patients With Chronic Hyponatremia: Extension to Studies CK-LX3401, 3405, and 3430
Official Title International, Multicenter Study of a Twenty-eight Week, Open-label, Titrated Oral Lixivaptan Administration in Patients With Chronic Hyponatremia: Extension to Studies CK-LX3401, 3405, and 3430
Brief Summary To evaluate the overall safety and continued efficacy of oral lixivaptan capsules in subjects with euvolemic and hypervolemic hyponatremia
Detailed Description Phase I and 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, LCWA and SIADH. Lixivaptan was previously evaluated in disease states characterized by hyponatremia with euvolemia (SIADH) and hyponatremia combined with fluid overload (HF, LCWA). Lixivaptan demonstrated correction in serum sodium concentration together with marked aquaresis in patients with hyponatremia.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with euvolemic or hypervolemic hyponatremia and who were enrolled in a randomized, blinded, placebo-controlled Phase III lixivaptan study of hyponatremia (CK-LX3401, CK-LX3405, or CK-LX3430)
Condition
  • Hyponatremia With Normal Extracellular Fluid Volume
  • Hyponatremia With Excess Extracellular Fluid Volume
Intervention Not Provided
Study Groups/Cohorts
  • CK-LX3401
    Patients with euvolemic or hypervolemic hyponatremia and who were enrolled in a randomized, blinded, placebo-controlled Phase III lixivaptan study of hyponatremia.
  • CK-LX3405
    Patients with euvolemic or hypervolemic hyponatremia and who were enrolled in a randomized, blinded, placebo-controlled Phase III lixivaptan study of hyponatremia
  • CK-LX3430
    Patients with euvolemic or hypervolemic hyponatremia and who were enrolled in a randomized, blinded, placebo-controlled Phase III lixivaptan study of hyponatremia
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 Completed
Actual Enrollment
 (submitted: June 20, 2011)
135
Original Estimated Enrollment
 (submitted: January 25, 2010)
150
Study Completion Date Not Provided
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Men and women 18 years of age or older
  2. Ability to provide informed consent or assent
  3. Prior participation in a lixivaptan hyponatremia trial with evidence of continued need or desire for therapy

Exclusion Criteria:

  1. A current medical condition where long-term treatment with an aquaretic agent may present an undue risk to the patient
  2. Hyponatremia which is acute, reversible, artificial or due to conditions not associated with vasopressin excess or likely to respond to aquaretic therapy
  3. Hyponatremia due to reversible medical condition or therapy
  4. Conditions associated with an independent imminent risk of morbidity and mortality
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01056848
Other Study ID Numbers CK-LX3431
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Cesare Orlandi, MD, Cardiokine Biopharma, LLC
Study Sponsor CardioKine Inc.
Collaborators
  • Cardiokine Biopharma, LLC
  • Biogen
Investigators Not Provided
PRS Account CardioKine Inc.
Verification Date June 2011