NCT03710395

Brief Summary

This study aims to investigate the influence of the c.421C\>A genetic polymorphism of the ABCG2 / BCRP transporter in the concentration ratio of nifedipine in maternal milk:plasma in hypertensive breastfeeding women attended at the Gynecology and Obstetrics Service of the Medical School of Ribeirão Preto, of the University of São Paulo. Thus, plasma and breast milk samples are being collected from patients in chronic use of the drug (n=30) within 15 to 30 days postnatal.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
19

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2015

Longer than P75 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 14, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 18, 2018

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

October 18, 2018

Status Verified

October 1, 2018

Enrollment Period

2.1 years

First QC Date

July 17, 2018

Last Update Submit

October 15, 2018

Conditions

Drug Transporter

Outcome Measures

Primary Outcomes (1)

  • Nifedipine concentration in plasma/milk ratio

    The concentration ratio will be determined as (nifedipine concentration in plasma)/(nifedipine concentration in breast milk).

    After reaching steady state (at least 15 days of treatment), samples will be collected before first nifedipine dosing in the morning.

Secondary Outcomes (2)

  • Nifedipine concentration in plasma

    After reaching steady state (at least 15 days of treatment), samples will be collected before first nifedipine dosing in the morning.

  • Nifedipine concentration in milk

    After reaching steady state (at least 15 days of treatment), samples will be collected before first nifedipine dosing in the morning.

Study Arms (2)

Wild homozygous for ABCG2 c.421C>A

ACTIVE COMPARATOR

Chronic hypertensive breastfeeding women (18-45 years old) genotyped as wild homozygous for ABCG2 c.421C\>A.

Procedure: Blood and breast milk samplingDrug: Nifedipine

Variant genotypes for ABCG2 c.421C>A

EXPERIMENTAL

Chronic hypertensive breastfeeding women (18-45 years old) genotyped as heterozygous or mutant homozygous for ABCG2 c.421C\>A.

Procedure: Blood and breast milk samplingDrug: Nifedipine

Interventions

Blood and breast milk samplingPROCEDURE

At least 15 days after starting treatment with 20 mg slow-release nifedipine every 12 hours. Blood and breast milk will be sampled before first dosing in the morning.

Also known as: Biological samples for nifedipine analysis
Variant genotypes for ABCG2 c.421C>AWild homozygous for ABCG2 c.421C>A
NifedipineDRUG

Chronic hypertensive breastfeeding women will be treated with slow-release 20 mg nifedipine, twice a day.

Also known as: 20 mg nifedipine (slow-release)
Variant genotypes for ABCG2 c.421C>AWild homozygous for ABCG2 c.421C>A

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Chronic hypertensive breastfeeding women
  • Patients being treated with 20 mg slow-release nifedipine every 12 hours for at least 15 days

You may not qualify if:

  • Patients in use of ABCG2 inhibitors (omeprazole, pantoprazole, ritonavir, saquinavir, imatinib, efavirenz, nicardipine, abacavir, tacrolimus, ciclosporin A, cannabidiol);
  • Patients who presented nifedipine adverse drug reactions
  • Patients whose blood pressure normalized after delivery
  • Patients who interrupted breastfeeding during the study
  • Patients who did not return to the hospital for the clinical protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Blood Specimen CollectionNifedipine

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesDihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Toxicology

Study Record Dates

First Submitted

July 17, 2018

First Posted

October 18, 2018

Study Start

December 14, 2015

Primary Completion

February 1, 2018

Study Completion

October 1, 2019

Last Updated

October 18, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share