A clinical trial to study the effect of conivaptan hydrochloride in patients with Euvolemic and Hypervolemic hyponatremia (a condition where the level of a chemical ion in blood goes below the normal levels)
- Conditions
- Health Condition 1: null- Euvolemic and Hypervolemic Hyponatremia
- Registration Number
- CTRI/2009/091/000400
- Lead Sponsor
- Ranbaxy Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 75
1.Patients of either sex, aged more than or equal to 18 years.
2.Patients who have mean serum sodium concentration between 115 and 129 mEq per liter both inclusive.
3.Patients who have serum osmolality less 290 mOsmol per kg water.
Mean serum sodium concentration refers to the mean of two serum sodium readings 0 and 4 hours obtained during the baseline period of 4 to 12 hours. For the patients in whom treatment of hyponatremia with conivaptan cannot be delayed, the sample at 0 hr will be considered as the baseline reading.
Note: Patients of either sex, aged more than or equal to 18 years
1.Patients unwilling or unable to give informed consent.
2.Random blood glucose more than or equal to 300 mg per dl.
3.Urinary sodium less tha 30mEq per liter with normal dietary salt intake.
4.Patients expected to have hyponatremia necessitating emergent treatment during the study.
5.Patients diagnosed with hypovolemic hyponatremia.
6.Patients diagnosed with congestive heart failure CHF NYHA class IV or Cirrhosis
7.Pregnant or lactating women or women in reproductive age group not using reliable contraception i.e. a medically accepted effective method of birth control
8.Patients with cardiac surgery, myocardial infarction, unstable angina or cerebrovascular accident in the past 3 months.
9.Patients with uncontrolled hypertension or supine systolic blood pressure less than 85 mmHg.
10.Patients with uncontrolled arrhythmias
11.Patients with creatinine clearance less than or equal to 30 ml per min per 1.73 m2.
12.Patients with urinary outflow obstruction unless catheterized.
13.Patients with abnormal laboratory values at admission into the study: SGOT or SGPT more than 3 times the upper limit of normal or serum albumin less than or equal to 1.5 g/dl.
14.Prothrombin time greater than 22 sec or an international normalized ratio greater than 2.0 without anticoagulant therapy or 3.0 or more with therapy.
15.Patients taking CYP3A4 inhibitors or substrates such as ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir, calcium channel blockers, digoxin or digitoxin, statins, benzodiazepines, vasopressin, oxytocin, desmopressin, carbamazepine, lithium, demeclocycline and urea.
16.Patients in whom another investigational drug defined as not approved for any indication by the local regulatory agency was used within 30 days of screening
17.Patients with any concurrent illness that could interfere with study treatment or its evaluation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method