A Phase 2 Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypovolemic Hyponatremia |
Drug: Tolvaptan Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
- 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. [ Time Frame: 4 and 7 days ] [ Designated as safety issue: No ]
- 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. [ Time Frame: 4 or 7 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 240 |
| Study Start Date: | May 2008 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Tolvaptan |
Drug: Tolvaptan
Tablet;15mg/tab;15/30/60mg/day for 7days Plus conventional therapy according to each patient's underlying disease, such as congestive heart failure, hepatic cirrhosis and SIADH or others.
|
| Placebo Comparator: Placebo |
Drug: Placebo
placebo plus conventional therapy according to each patient's underlying disease, such as congestive heart failure, hepatic cirrhosis and SIADH or others.
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Informed consent.
- Age:18～75 (when informed consent is obtained)，male or female.
- 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)
- In-patient subjects.
Contacts and Locations| China, Human | |
| Department of Cardiology, the Third Xiangya Hospital, Central South University | |
| Changsha, Human, China | |
| China, Hunan | |
| Department of Cardiology, Xiangya Hospital, Central South University | |
| Changsha, Hunan, China | |
| China, Jinlin | |
| Cardiology, Jilin University Second Hospital | |
| Changchun, Jinlin, China | |
| China, Sichuan | |
| Endocrinology, West China Hospital Sichuan University | |
| Chengdu, Sichuan, China | |
| China | |
| Endocrinology, No. 301 hospital | |
| Beijing, China | |
| Cardiology/Endocrinology/Infection, Beijing University First Hospital | |
| Beijing, China | |
| Cardiology / Hepatology, Beijing Friendship Hospital | |
| Beijing, China | |
| Cardiology / Endocrinology, Peking Union Medical College Hospital | |
| Beijing, China | |
| Hepatology, Beijing Renmin Hospital | |
| Beijing, 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, China | |
| Principal Investigator: | Wenling Zhu | Peking Union Medical College Hospital |
| Principal Investigator: | Feng Gu | Peking Union Medical College Hospital |
| Principal Investigator: | Jidong Jia | Beijing Friendship Hospital |
More Information
No publications provided
| Responsible Party: | Yong Jin / Project Manager, Otsuka Beijing Research Institute |
| ClinicalTrials.gov Identifier: | NCT00664014 History of Changes |
| Other Study ID Numbers: | 156-07-802-01 |
| Study First Received: | April 14, 2008 |
| Last Updated: | March 5, 2010 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Otsuka Beijing Research Institute:
|
hyponatremia Non-acute and non hypovolemic hyponatremia |
Additional relevant MeSH terms:
|
Hyponatremia Hypovolemia Water-Electrolyte Imbalance Metabolic Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013