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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

2014-08-27 03:16:21 | BioPortfolio

Summary

To evaluate the overall safety and continued efficacy of oral lixivaptan capsules in subjects with euvolemic and hypervolemic hyponatremia

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Conditions

Euvolemic Hyponatremia

Location

Torrance Clinical Research
Lomita
California
United States
90717

Status

Recruiting

Source

CardioKine Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:21-0400

Clinical Trials [41 Associated Clinical Trials listed on BioPortfolio]

An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia

This study will investigate the application of a vasopressin antagonist in the treatment of hyponatremia most likely caused by inappropriate AVP secretion. The population studied will inc...

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

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...

Study of Efficacy & Safety of Oral YM087 in Subjects With Euvolemic or Hypervolemic Hyponatremia

Study of efficacy & safety of oral YM087 in subjects with euvolemic or hypervolemic hyponatremia

Establishment of an Algorithm for a Clinical Classfication of Hypoosmolar Hyponatremia

The prospective clinical diagnosis of hyponatremia is often very difficult- but requirement for an appropriate and riskless treatment of hyponatremia. This study try to establish an algori...

Hyponatremia in the Prevention of Hospitalized Patients Falls

Cross ecological quasi-experimental study to assess effectiveness of early intervention in the diagnosis and treatment of hyponatremia in the prevention of hospitalized patients´ falls.

PubMed Articles [42 Associated PubMed Articles listed on BioPortfolio]

Prevalence of hypothyroidism in patients with hyponatremia: A retrospective cross-sectional study.

Hypothyroidism has been suggested to be an uncommon cause of hyponatremia. However, little is known about the prevalence of hypothyroidism in patients with different levels of hyponatremia. The object...

Approach to the syndrome of inappropriate antidiuretic hormone secretion (SIADH).

The syndrome of inappropriate antidiuretic hormone secretion (SIADH) is defined by euvolemic hyponatremia due to an inappropriate retention of free water under the effect of antidiuretic hormone. It i...

Influence of outdoor temperature and relative humidity on incidence and etiology of hyponatremia.

Hyponatremia is the most common electrolyte disturbance in hospitalized patients. Known risk factors are heart or renal failure, excessive drinking or the use of diuretics. The incidence of hyponatrem...

Hyponatremia in the light of the most recent guidelines - diagnostics and differential diagnosis.

Hyponatremia is still considered as a challenge of today's medicine. It is an independent factor responsible for the increased mortality among hyponatremic population and its clinical expression might...

Hyponatremia in Acute Heart Failure in Relation to Hematocrit Levels: Clinical Relevance and Prognostic Implication.

Hyponatremia is the most common electrolyte abnormality found in hospitalized patients with acute heart failure (AHF) and is related to poor prognosis. This study sought to evaluate: (1) the different...

Medical and Biotech [MESH] Definitions

A demyelinating condition affecting the PONS and characterized clinically by an acute progressive QUADRIPLEGIA; DYSARTHRIA; DYSPHAGIA; and alterations of consciousness. Pathologic features include prominent demyelination in the central PONS with sparing of axons and neurons. This condition is usually associated with systemic disorders such as HYPONATREMIA; chronic ALCOHOLISM; LIVER FAILURE; severe BURNS; malignant NEOPLASMS; hemorrhagic PANCREATITIS; HEMODIALYSIS; and SEPSIS. The rapid medical correction of hyponatremia has been cited as a cause of this condition. (From Adams et al., Principles of Neurology, 6th ed, pp1125-6)

Deficiency of sodium in the blood; salt depletion. (Dorland, 27th ed)

A clinical disorder characterized by excessive fluid intake (polydipsia); HYPONATREMIA; and POLYURIA in SCHIZOPHRENIA and other psychiatric disorders. Impaired water metabolism in psychogenic polydipsia can result in WATER INTOXICATION.

A condition of HYPONATREMIA and renal salt loss attributed to overexpansion of BODY FLUIDS resulting from sustained release of ANTIDIURETIC HORMONES which stimulates renal resorption of water. It is characterized by normal KIDNEY function, high urine OSMOLALITY, low serum osmolality, and neurological dysfunction. Etiologies include ADH-producing neoplasms, injuries or diseases involving the HYPOTHALAMUS, the PITUITARY GLAND, and the LUNG. This syndrome can also be drug-induced.

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