NCT01290445 is a clinical trial of varenicline in Malformations, sponsored by Pfizer.

Who is sponsoring NCT01290445?

NCT01290445 is sponsored by Pfizer.

What drugs are being tested in NCT01290445?

Interventions in NCT01290445: varenicline, cigarette smoke from maternal smoking, Non-Exposure.

What condition does NCT01290445 study?

NCT01290445 studies Malformations.

Is NCT01290445 still recruiting?

NCT01290445 is currently completed. Last updated 24 July 2023.

Are results published for NCT01290445?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-07-24 · How we verify

NCT01290445

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Varenicline Pregnancy Cohort Study

Completed Results posted Last updated 24 July 2023

What this trial tests

trial testing varenicline in Malformations in 885,185 participants. Completed in 1 May 2016.

Timeline

13 September 2007

Primary endpoint
1 May 2016

1 May 2016

Quick facts

Lead sponsor	Pfizer
Status	Completed
Study type	OBSERVATIONAL
Enrollment	885,185
Start date	13 September 2007
Primary completion	1 May 2016
Estimated completion	1 May 2016

Drugs / interventions tested

varenicline (varenicline) — full drug profile →
cigarette smoke from maternal smoking
Non-Exposure

Conditions studied

Malformations — all drugs for Malformations →

Sponsor

Pfizer — full company profile →

Who can join

Eligibility, any sex, with Malformations. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Infants With Major Congenital Malformations Primary · For 12 months after birth

Major congenital malformations were defined as any codes within the Q-chapter of The Tenth Revision of the International Classification of Diseases (ICD-10), excluding certain minor anomalies.

Group	Value	95% CI
Varenicline Exposed Cohort	12
Varenicline Unexposed Cohort	3382
Reference Cohort	33950

Number of Infants With Stillbirths Secondary · At the time of birth

Stillbirth was defined as death at a gestational age of greater than or equal to (\>=) 22 weeks, with the exception that in Sweden prior to 2008 it was defined as death at a gestational age of \>=28 weeks.

Group	Value	95% CI
Varenicline Exposed Cohort	1
Varenicline Unexposed Cohort	384
Reference Cohort	2418

Number of Infants Born Small for Gestational Age (SGA) Secondary · At the time of birth

An infant was defined as SGA if birth weight was below the 10th percentile of its sex-specific national distribution at the respective gestational week. Data on birth weight and gestational age from the medical birth registries were used to calculate the 10th percentiles for each sex based on all Danish and Swedish births during the study observation period.

Group	Value	95% CI
Varenicline Exposed Cohort	42
Varenicline Unexposed Cohort	13433
Reference Cohort	73135

Number of Infants Born Preterm Secondary · At the time of birth

Preterm birth was defined as birth before the gestational age of 37 weeks.

Group	Value	95% CI
Varenicline Exposed Cohort	25
Varenicline Unexposed Cohort	6173
Reference Cohort	46732

Number of Infants Born To Mothers Diagnosed With Premature Rupture of Membranes Secondary · At the time of birth

Group	Value	95% CI
Varenicline Exposed Cohort	12
Varenicline Unexposed Cohort	4246
Reference Cohort	30641

Number of Infants Diagnosed With Sudden Infant Death Syndrome (SIDS) Secondary · For 12 months after birth

Sudden Infant Death Syndrome (SIDS) was defined as a sudden unexplained death of an infant less than one year of age.

Group	Value	95% CI
Varenicline Exposed Cohort	0
Varenicline Unexposed Cohort	51
Reference Cohort	58

Sponsor's own description

A prospective population-based cohort study to examine whether varenicline use during pregnancy is associated with an increased risk of major congenital malformations in infants above that associated with smoking during pregnancy.

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:

Other trials of varenicline

Trials testing the same drug.

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NCT02854800 — Smoking Cessation & Opioid Dependence Treatment Integration · Phase 2, PHASE3 · completed
NCT01771627 — Varenicline or Nicotine Patch in Promoting Smoking Cessation Among Current Smokers · NA · completed
NCT00781755 — Treating Schizophrenic Smokers: Effects on Craving, Cues and Withdrawal · Phase 4 · withdrawn

Other Pfizer 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01290445 (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 Pfizer
Last refreshed: 24 July 2023

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/NCT01290445.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing