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Trial record 72 of 143 for:    NIFEDIPINE

Nifedipine Metabolism in Pregnancy

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ClinicalTrials.gov Identifier: NCT03654378
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Sponsor:
Collaborator:
University of Illinois at Chicago
Information provided by (Responsible Party):
Katherine Wisner, Northwestern University

Brief Summary:
The objectives of this application are to provide mechanistic understanding of altered drug metabolism by hepatic cytochrome CYP3A4 and to translate the findings to human pregnancy. A drug metabolized by CYP3A4, Nifedipine, will be the drug of choice mechanism to understand the enzyme's induction. Pregnant women currently on Nifedipine to treat high blood pressure will be recruited. If the women enroll, the women will participate in four pharmacokinetic (PK) studies (one per trimester, and one postpartum).

Condition or disease
Hypertension Hypertension Pregnancy

Detailed Description:

The purpose of this research is to understand changes in a woman's body during pregnancy, specifically how the body processes medication during pregnancy.

The investigators know that over 90% of women take at least one drug during pregnancy. Because of the changes in a pregnant women's body, processes such as the rate of drug metabolism can change over the course of the three trimesters.

Drug metabolism is sometimes controlled by certain genes in the body. This study will be examining the up-regulation, or "speeding up" of a certain gene called CYP3A4, a gene that helps the body process Nifedipine, a drug commonly used to treat high blood pressure.

The primary goal of this research is to understand how drug metabolism changes across pregnancy. The secondary goal for this research is to define how enzymes in the liver act to up-regulate CYP3A4 during pregnancy. This research will help to build a knowledge base for the prediction of drug metabolism changes and the design of optimal individualized dosage regimens for pregnant women.

The results of this study are expected to have a positive impact, as they will lay a foundation for the design of individualized drug therapy during pregnancy. This foundation will minimize the risk of over- and under-dosing pregnant women.


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Study Type : Observational
Estimated Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Defining Factors Responsible for Temporal Changes in CYP3A4-Mediated Drug Metabolism During Pregnancy
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Nifedipine




Primary Outcome Measures :
  1. Change in concentration-to-dose ratio of Nifedipine in plasma [ Time Frame: Between 2-16 weeks, 17-26 weeks, 27-39 weeks and 3 months postpartum. ]

Secondary Outcome Measures :
  1. Change in thyroid hormone levels in plasma [ Time Frame: Between 2-16 weeks, 17-26 weeks, 27-39 weeks and 3 months postpartum. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community sample of women taking Nifedipone XR in areas surrounding Chicago, IL.
Criteria

Inclusion Criteria:

  • Age 18-45 years
  • Pregnant, prior to 16 weeks gestation
  • Hypertension treated with oral extended-release nifedipine
  • Singleton gestation

Exclusion Criteria:

  • Current use of other therapies for hypertension
  • Chronic use of prescription drugs that are substrates or inhibitors of CYP3A4 enzyme activity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03654378


Contacts
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Contact: Minaz K Cattan, M.D. 312-695-7190 minaz.kolia@northwestern.edu
Contact: Gabrielle Mesches, M.S. 312-695-6684 gabrielle.mesches@northwestern.edu

Locations
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United States, Illinois
Northwestern University Asher Center for the Study and Treatment of Depressive Disorders Recruiting
Chicago, Illinois, United States, 60611
Contact: Minaz K Cattan, M.D.    312-695-7190    minaz.kolia@northwestern.edu   
Contact: Gabrielle A Mesches, M.S.    312-695-6684    gabrielle.mesches@northwestern.edu   
Principal Investigator: Katherine L Wisner, M.D., M.S.         
Sponsors and Collaborators
Northwestern University
University of Illinois at Chicago
Investigators
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Principal Investigator: Katherine L Wisner, M.D., M.S. Northwestern University
Principal Investigator: Hyunyoung Jeong, PharmD, PhD University of Illinois at Chicago

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Responsible Party: Katherine Wisner, Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT03654378     History of Changes
Other Study ID Numbers: NICHD-1 R01 HD089455-01A1
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Katherine Wisner, Northwestern University:
Nifedipine
Pregnancy
Hypertension
Additional relevant MeSH terms:
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Nifedipine
Hypertension
Vascular Diseases
Cardiovascular Diseases
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents