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Trial record 1 of 147 for:    NIFEDIPINE
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Genetic Polymorphisms of ABCG2/BCRP on the Transport of Nifedipine to Breast Milk.

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ClinicalTrials.gov Identifier: NCT03710395
Recruitment Status : Active, not recruiting
First Posted : October 18, 2018
Last Update Posted : October 18, 2018
Sponsor:
Collaborator:
Hospital das Clínicas de Ribeirão Preto
Information provided by (Responsible Party):
Natalia Valadares de Moraes, Universidade Estadual Paulista Júlio de Mesquita Filho

Tracking Information
First Submitted Date  ICMJE July 17, 2018
First Posted Date  ICMJE October 18, 2018
Last Update Posted Date October 18, 2018
Actual Study Start Date  ICMJE December 14, 2015
Actual Primary Completion Date February 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2018)
Nifedipine concentration in plasma/milk ratio [ Time Frame: After reaching steady state (at least 15 days of treatment), samples will be collected before first nifedipine dosing in the morning. ]
The concentration ratio will be determined as (nifedipine concentration in plasma)/(nifedipine concentration in breast milk).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2018)
  • Nifedipine concentration in plasma [ Time Frame: After reaching steady state (at least 15 days of treatment), samples will be collected before first nifedipine dosing in the morning. ]
    The concentration of nifedipine in plasma determined by HPLC.
  • Nifedipine concentration in milk [ Time Frame: After reaching steady state (at least 15 days of treatment), samples will be collected before first nifedipine dosing in the morning. ]
    The concentration of nifedipine in breast milk determined by HPLC.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Genetic Polymorphisms of ABCG2/BCRP on the Transport of Nifedipine to Breast Milk.
Official Title  ICMJE Influence of Genetic Polymorphisms of ABCG2/BCRP on the Transport of Nifedipine to Breast Milk in Hypertensive Breastfeeding Women.
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.
Detailed Description The breast cancer resistance protein (ABCG2/BCRP) human transporter, encoded by the ABCG2 gene, is highly expressed on the human lactating breast. Nifedipine, a known substrate of ABCG2, is used for the treatment of hypertension in pregnancy and during breastfeeding. ABCG2 plays an important role on secreting drugs and xenobiotics into milk. The aim of the present study was to evaluate the effect of ABCG2 c.421C>A on nifedipine breast milk/plasma concentration ratio in hypertensive breastfeeding women. Nineteen hypertensive breastfeeding women treated with 20 mg slow-release nifedipine every 12 hours were investigated. Blood and breast milk samples were collected simultaneously 15-30 days after delivery and at least 15 days after drug treatment, in order to reach drug steady state. All patients were genotyped for ABCG2 c.421C>A using real time-PCR. Nifedipine concentration was determined in plasma and breast milk by high-performance liquid chromatography using UV detection. The comprehension of the variability in the transport of nifedipine to breast milk in hypertensive breastfeeding women will contribute to the evaluation of drug exposure in breast-fed infants to nifedipine and other ABCG2 substrates.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Drug Transporter
Intervention  ICMJE
  • Procedure: Blood and breast milk sampling
    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.
    Other Name: Biological samples for nifedipine analysis
  • Drug: Nifedipine
    Chronic hypertensive breastfeeding women will be treated with slow-release 20 mg nifedipine, twice a day.
    Other Name: 20 mg nifedipine (slow-release)
Study Arms  ICMJE
  • Active Comparator: Wild homozygous for ABCG2 c.421C>A
    Chronic hypertensive breastfeeding women (18-45 years old) genotyped as wild homozygous for ABCG2 c.421C>A.
    Interventions:
    • Procedure: Blood and breast milk sampling
    • Drug: Nifedipine
  • Experimental: Variant genotypes for ABCG2 c.421C>A
    Chronic hypertensive breastfeeding women (18-45 years old) genotyped as heterozygous or mutant homozygous for ABCG2 c.421C>A.
    Interventions:
    • Procedure: Blood and breast milk sampling
    • Drug: Nifedipine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 15, 2018)
19
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2019
Actual Primary Completion Date February 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03710395
Other Study ID Numbers  ICMJE NIFEDABCG2BCRP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Natalia Valadares de Moraes, Universidade Estadual Paulista Júlio de Mesquita Filho
Study Sponsor  ICMJE Natalia Valadares de Moraes
Collaborators  ICMJE Hospital das Clínicas de Ribeirão Preto
Investigators  ICMJE Not Provided
PRS Account Universidade Estadual Paulista Júlio de Mesquita Filho
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP