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NCT01638663
Effect of Vasopressin Antagonism on Renal Sodium and Water Handling and Circulation During Inhibition of the Nitric Oxide System in Healthy Subjects
Phase 2 trial testing Tolvaptan in Cardiovascular Diseases in 20 participants. Completed in 1 March 2014.
1 March 2014
Quick facts
| Lead sponsor | Regional Hospital Holstebro |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 May 2012 |
| Primary completion | 1 March 2014 |
| Estimated completion | 1 March 2014 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Tolvaptan (TOLVAPTAN) — full drug profile →
- Placebo
Conditions studied
- Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
- Nephropathy — all drugs for Nephropathy →
Sponsor
Regional Hospital Holstebro
Who can join
Adults 18 to 40, any sex, with Cardiovascular Diseases or Nephropathy. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
CH2O
Time frame: 5-6 Hours
Measurement of H2O clearance at baseline, during and after L-NMMA infusion.
Sponsor's own description
The purpose of this study is to investigate the effect of tolvaptan on renal water, sodium and potassium excretion, plasma concentration of vasoactive hormones,central blood pressure, pulse wave velocity (PWV) and augmentation index, basal and during inhibition of nitric oxide synthesis in healthy subjects.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01638663
- 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 recruiting trials for Cardiovascular Diseases
Currently open trials in the same condition.
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Other Regional Hospital Holstebro trials
Trials by the same sponsor.
- NCT05165823 — The Significance of Sodium Balance and the Value of Salt-blood Test in Identifying Salt Sensitive Patients · NA · completed
- NCT04363554 — The Kidneys Ability to Concentrate and Dilute Urine in Patients With Autosomal Dominant Polycystic Kidney Disease · NA · completed
- NCT06019026 — Five-year Migration Pattern and Bone Mineral Density for the Tri-Lock and Summit Femoral Stems. · NA · 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 NCT01638663 (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 Regional Hospital Holstebro
- Last refreshed: 8 October 2014
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/NCT01638663.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing