A Phase 2 Efficacy and Safety Study of the Tolvaptan Tablets in Patients with Non-hypovolemic Non-acute Hyponatremia

Phase 2

Completed

• Conditions: Hypovolemic Hyponatremia
• Interventions: Drug: Tolvaptan; Drug: Placebo

• Registration Number: NCT00664014
• Lead Sponsor: Otsuka Beijing Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-04-14
• Study First Submitted QC: 2008-04-21
• Study First Posted: 2008-04-22
• Study Start: 2008-05
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tolvaptan	Tolvaptan	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (13)

Endocrinology, No. 301 hospital; 🇨🇳 Beijing, China

Hepatology, Beijing Renmin Hospital; 🇨🇳 Beijing, China

Department of Cardiology, the Third Xiangya Hospital, Central South University; 🇨🇳 Changsha, Hunan, China

Department of Cardiology, Xiangya Hospital, Central South University; 🇨🇳 Changsha, Hunan, China

Cardiology, Jilin University Second Hospital; 🇨🇳 Changchun, Jilin, China

Endocrinology, West China Hospital Sichuan University; 🇨🇳 Chengdu, Sichuan, 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

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