Last reviewed · How we verify
NCT00977249
Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users. A Double Blind, Placebo Controlled Trial
Phase 2/Phase 3 trial testing support and visits in Tobacco Dependence in 200 participants. Status unknown.
1 December 2011
Quick facts
| Lead sponsor | University Hospital, Gentofte, Copenhagen |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 1 September 2009 |
| Primary completion | 1 December 2011 |
| Estimated completion | 1 December 2011 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- support and visits
- varenicline (varenicline) — full drug profile →
- placebo
Conditions studied
- Tobacco Dependence — all drugs for Tobacco Dependence →
Sponsor
University Hospital, Gentofte, Copenhagen
Who can join
18 and older, any sex, with Tobacco Dependence. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml
Time frame: 12 weeks +/- 1 week
Sponsor's own description
Primary aim: Will varenicline be better than placebo to get long-term users of NRT to stop? Secondary aim: To assess in details some side effects of varenicline i.e. nausea and abnormal dreams.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT00977249
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University Hospital, Gentofte, Copenhagen trials
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 NCT00977249 (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 University Hospital, Gentofte, Copenhagen
- Last refreshed: 14 September 2009
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/NCT00977249.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing