Hypovolemic Hyponatremia Clinical Trial
Official title:
Randomized, Double-blind, Multicenter, Placebo-controlled (Standard Therapy + Placebo), Phase 2 Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia
| Verified date | March 2010 |
| Source | Otsuka Beijing Research Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: Food and Drug Administration |
| Study type | Interventional |
This is a randomized, double-blind, multicenter, placebo-controlled (standard therapy + placebo), phase 2 efficacy and safety study of the Tolvaptan tablets in treatment of patients with non-hypovolemic non-acute hyponatremia arising from a variety of etiologies. 240 (120 in each group) patients are to be enrolled randomly into Tolvaptan group or placebo group. Subjects in Tolvaptan group will receive standard therapy + Tolvaptan (15-60mg/day), while those in control group receiving standard therapy + placebo. The starting dose of tolvaptan is 15mg and it could be titrated up to 30mg and then,if necessary, to the maximum of 60mg according to a certain titration scheme based on patients' response of serum sodium level. The study includes a 2-day screening period from day -2 to day -1, 7-day inpatient study treatment (day 1 to day 7 ). After study treatment, subjects will be Followed-up on safety events on day 14 - 16. The Primary Efficacy Variable is the change of serum sodium from baseline. For patients with Congestive Heart Failure (CHF) or hepatic cirrhosis, change of body weight, fluid balance and symptoms improvement of CHF and hepatic edema will be assessed as secondary efficacy variables.
| Status | Completed |
| Enrollment | 240 |
| Est. completion date | February 2010 |
| Est. primary completion date | February 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: 1. Informed consent. 2. Age:18~75 (when informed consent is obtained),male or female. 3. Non-hypovolemic and non acute hyponatremia with a Serum sodium < 135mEq/L before randomization. (main underlying diseases include CHF, hepatic cirrhosis with edema, SIADH and others) 4. In-patient subjects. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Cardiology / Endocrinology, Peking Union Medical College Hospital | Beijing | |
| China | Cardiology / Hepatology, Beijing Friendship Hospital | Beijing | |
| China | Cardiology/Endocrinology/Infection, Beijing University First Hospital | Beijing | |
| China | Endocrinology, No. 301 hospital | Beijing | |
| China | Hepatology, Beijing Renmin Hospital | Beijing | |
| China | Cardiology, Jilin University Second Hospital | Changchun | Jinlin |
| China | Department of Cardiology, the Third Xiangya Hospital, Central South University | Changsha | Human |
| China | Department of Cardiology, Xiangya Hospital, Central South University | Changsha | Hunan |
| China | Endocrinology, West China Hospital Sichuan University | Chengdu | Sichuan |
| China | Hepatology/Endocrinology, Chongqing Medical University Second Hospital | Chongqing | |
| China | Hepatology / Endocrinology, Shanghai Changzheng Hospital | Shanghai | |
| China | Cardiology, Tianjin Medical University Second Hospital | Tianjin | |
| China | Endocrinology, Tianjin General Hospital | Tianjin |
| Lead Sponsor | Collaborator |
|---|---|
| Otsuka Beijing Research Institute | Otsuka Pharmaceutical Co., Ltd. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The change of average daily Area Under the Curve (AUC) of serum sodium by day 4 and 7 comparing with baseline serum sodium level within the double-blind therapy period. | 4 and 7 days | No | |
| Secondary | For CHF and hepatic edema patients, improvement of symptoms and relevant physical examination measures or ultrasound test findings . Other secondary efficacy variables on blood serum sodium, fluid balance or body weight change. | 4 or 7 days | No |