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NCT01026961
A Randomized, Crossover, Double-Blind Study To Evaluate The Safety Of An Association Of Phenylephrine Hydrochloride 10mg + Acetaminophen 500mg + Dimethindene Maleate 1 Mg Compared To Phenylephrine Hydrochloride 10mg In Healthy Volunteers
Phase 1/Phase 2 trial testing Phenylephrine HCL in Heart Rate. Withdrawn.
1 November 2010
Quick facts
| Lead sponsor | Novartis |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Start date | 1 September 2010 |
| Primary completion | 1 November 2010 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Phenylephrine HCL — full drug profile →
- Phenylephrine HCL/Acetaminophen/Dimethindene Maleate — full drug profile →
Conditions studied
- Heart Rate — all drugs for Heart Rate →
- Blood Pressure — all drugs for Blood Pressure →
- Arrhythmias — all drugs for Arrhythmias →
Sponsor
Novartis — full company profile →
Who can join
Adults 18 to 50, any sex, with Heart Rate or Blood Pressure. 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.
-
To compare the effect of phenylephrine hydrochloride 10mg + acetaminophen 500mg + dimethindene maleate 1mg and phenylephrine hydrochloride 10mg alone on vital signs
Time frame: 15 days
Sponsor's own description
This study will evaluate the safety of phenylephrine hydrochloride 10 mg + acetaminophen 500 mg + dimethindene maleate 1 mg compared to phenylephrine hydrocloride 10 mg alone in healthy volunteers.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01026961
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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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 NCT01026961 (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 Novartis
- Last refreshed: 2 March 2016
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/NCT01026961.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing