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Lixivaptan

Phase 3

Euvolemic Hyponatremia | Small molecule | Other |Biogen Inc.|Last Updated: Jun 28, 2011

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment206

FDA Designations

No designations recorded

Clinical trial landscape

Lixivaptan · 4 trials · 4 indications

Phase 3 3Phase 1 1
NCT00876798A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of Oral Lixivaptan Capsules in Subjects With Euvolemic HyponatremiaEuvolemic Hyponatremia
COMPLETED206 Analytics
NCT00660959Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Oral Lixivaptan Capsules in Subject With Euvolemic HyponatremiaHyponatremia With Normal Extracellular Fluid Volume
COMPLETED106 Analytics
NCT00578695THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient EvaluationHyponatremia
COMPLETED652 Analytics
PHASE3COMPLETED
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of Oral Lixivaptan Capsules in Subjects With Euvolemic Hyponatremia
Euvolemic Hyponatremia
NCT00876798206
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PHASE3COMPLETED
Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Oral Lixivaptan Capsules in Subject With Euvolemic Hyponatremia
Hyponatremia With Normal Extracellular Fluid Volume
NCT00660959106
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PHASE3COMPLETED
THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation
Hyponatremia
NCT00578695652
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Study Endpoints

Primary Endpoints

To demonstrate that lixivaptan is safe and effective in achieving and maintaining increased serum sodium concentration in subjects with SIADH and other conditions of euvolemic hyponatremia.
6 months
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
60 days
To determine whether lixivaptan can effectively and safely produce an increase in serum sodium from Baseline in heart failure subjects with hyponatremia and volume overload. Effects on body weight and other clinical measures will be evaluated.
60 days
Timed-matched, placebo-corrected, changed from Baseline in QTc
7days

Secondary Endpoints

If lixivaptan demonstrates improvement in serum sodium, % of subjects achieving normalized serum sodium, % of subjects requiring fluid restriction, prevention of worsening hyponatremia, and the change from baseline to complete TMT-B.
6 months
Change from baseline in serum sodium on Day 30
60 days
Percentage of subjects achieving normalized serum sodium (Na+ ≥ 135 mEq/L)
60 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALLixivaptan
2PLACEBO_COMPARATORPlacebo
Active ComparatorEXPERIMENTALlixivaptan
PlaceboPLACEBO_COMPARATORplacebo
ActiveEXPERIMENTALLixivaptan
APLACEBO_COMPARATORPlacebo by mouth
BEXPERIMENTALlixivaptan
CACTIVE_COMPARATORmoxifloxacin

Interventions

NameTypeDescription
LixivaptanDRUGCapsules, 25mg lixivaptan or matching placebo once daily. Study medication can be titrated up to 50mg or 100mg once daily. Acceptable dosages are once daily administration of 25mg, 50mg, or 100mg as a single dose.
PlaceboDRUGCapsule. Subjects will be randomized (3:1) on an outpatient basis to 25 mg lixivaptan or matching placebo, once daily.
moxifloxacinDRUGtablets
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites90

Inclusion Criteria: 1. Written informed consent. 2. Men or women aged 18 or older. 3. Diagnosis of euvolemic hyponatremia (Na+ \< 135 mEq/L). 4. Willing to be observed in a monitored setting for approximately the first 8 hours following treatment initiation (first dose). 5. In the Investigator's ju...

Countries:United StatesBelgiumCzechiaIndiaIsraelItalyMexicoPeruCanadaGermanyPolandArgentinaChileRomaniaRussiaSlovakiaSpainSwitzerland
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Frequently asked questions about Lixivaptan

What is Lixivaptan used for?

Lixivaptan is an investigational small molecule being developed for hyponatremia, including euvolemic hyponatremia and hyponatremia with normal extracellular fluid volume. It is also being studied in healthy volunteers for ECG effects. The drug is in Phase 3 clinical development and is not yet approved by the FDA.

Who makes Lixivaptan?

Lixivaptan is being developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol BIIB. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with hyponatremia.

What phase is Lixivaptan in?

Lixivaptan is in Phase 3 clinical development for hyponatremia. It has completed multiple Phase 3 trials, including the BALANCE study and two studies in euvolemic hyponatremia. The drug remains investigational and has not received FDA approval.

What clinical trials is Lixivaptan in?

Lixivaptan has completed several clinical trials, including NCT00578695 (BALANCE study in hyponatremia), NCT00660959 (euvolemic hyponatremia), NCT00675701 (ECG effects in healthy volunteers), and NCT00876798 (safety and tolerability in euvolemic hyponatremia). All trials are completed with a total enrollment of 652 patients.

Is Lixivaptan FDA approved?

No, Lixivaptan is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for hyponatremia. The completed trials have evaluated its efficacy and safety, but the drug has not yet received regulatory approval for marketing.