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NCT02352285: AQUATIC
Assessment of Clinical Outcome and Treatment Quality Under Adequate Use of Tolvaptan In Correction of Hyponatremia in Patients Hospitalized With Worsening Heart Failure and Hyponatremia
Phase 4 trial testing Tolvaptan in Heart Failure With Hyponatremia in 58 participants. Terminated before completion.
1 January 2017
Quick facts
| Lead sponsor | Korea Otsuka Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 58 |
| Start date | 1 December 2012 |
| Primary completion | 1 January 2017 |
| Estimated completion | 1 January 2017 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Tolvaptan (TOLVAPTAN) — full drug profile →
- Placebo
Conditions studied
- Heart Failure With Hyponatremia — all drugs for Heart Failure With Hyponatremia →
Sponsor
Korea Otsuka Pharmaceutical Co., Ltd. — full company profile →
Who can join
20 and older, any sex, with Heart Failure With Hyponatremia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Average daily AUC of change from baseline in serum Na level to day 4 within the double-blind treatment period
Time frame: from baseline to day 4
Sponsor's own description
The objective is to evaluate the efficacy and safety on the tolvaptan for increasing serum Na levels in patients with worsening heart failure and hyponatremia.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02352285
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Tolvaptan
Trials testing the same drug.
- NCT06506994 — A Study of HRS-9057 in Patients With Heart Failure and Volume Overload · Phase 1 · completed
- NCT06171100 — Low-dose Tolvaptan for Inpatient Hyponatraemia. · unknown
- NCT05569655 — Efficacy and Safety Evaluation of Tolvaptan in the Treatment of Patients With RHF Caused by PAH · NA · unknown
- NCT03949894 — Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domI · Phase 4 · completed
- NCT03764605 — Metformin vs Tolvaptan for Treatment of Autosomal Dominant Polycystic Kidney Disease · Phase 3 · unknown
Other Korea Otsuka Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT06674291 — Registry on the Effectiveness and Safety of the 9-month MDR-END Treatment Regimen in Korean Patients with FQ-sensitive M · not yet recruiting
- NCT05048069 — Post-Marketing Surveillance of Safety and Effectiveness of Mucosta®SR Tab. · unknown
- NCT04189705 — A Study to Evaluate the Efficacy and Safety of MCT-SR in Patients With Gastritis · Phase 3 · completed
- NCT04150146 — To Evaluate Food Effect on the Pharmacokinetics of Rebamipide in Healthy Volunteers · Phase 1 · completed
- NCT03949894 — Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domI · Phase 4 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02352285 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Korea Otsuka Pharmaceutical Co., Ltd.
- Last refreshed: 12 June 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02352285.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing