Chronic Hypertension in PregnancyPhase 4NCT02353806
Pharmacokinetics of Amlodipine Besylate at Delivery and During Lactation
A Phase 4 study testing Amlodipine besylate in people with Chronic Hypertension in Pregnancy, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This is a phase IV prospective trial to collect and analyze information about the maternal pharmacokinetics of amlodipine besylate at the time of delivery and during postpartum lactation. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Chronic Hypertension in Pregnancy
- What is being tested?
- Amlodipine besylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Sep 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18 years or older;
- Pregnant female
- Already taking amlodipine 5 mg for treatment of chronic hypertension in pregnancy;
- Hospitalized following routine term vaginal delivery or uncomplicated cesarean delivery
- Breastfeeding or breast and bottle-feeding their infant
Who cannot join
- Known kidney disease
- Delivery complicated by chorioamnionitis, endometritis or postpartum hemorrhage
- Administration of greater than 5 mg of amlodipine in 24 hour period
Trial locations and contacts
1 site in 1 country.
United States1 site
Parkland Health and Hospital System
Dallas, Texas, 75235
About this study
This is a phase IV prospective trial to collect and analyze information about the maternal pharmacokinetics of amlodipine besylate at the time of delivery and during postpartum lactation. The study will also evaluate amlodipine concentrations in the infants of breastfeeding mothers who are taking amlodipine besylate for treatment chronic hypertension.
Read the detailed description
We plan to evaluate the pharmacokinetics of amlodipine besylate at the time of delivery, to determine if transplacental passage of the drug occurs. We will also examine the drug kinetics in postpartum lactation to establish whether amlodipine is excreted into breast milk. The outcomes of interest are plasma concentration of amlodipine at delivery and the drug concentrations in blood and breast milk over a twenty-hour steady-state period following milk-supply establishment. Fifteen patients already taking 5 mg of amlodipine during pregnancy for the treatment of chronic hypertension will be recruited from the antepartum Obstetric Complications Clinic at Parkland Hospital. Only women who are breastfeeding will be eligible for the study. Patients who elect to participate in the study will continue their amlodipine 5 mg dosing through delivery and into the postpartum period. Maternal blood will be drawn within one hour of delivery and fetal cord blood collected at the time of delivery. Patients will then have blood drawn over a 24 hour period beginning on postpartum day 2 after delivery following administration of their once-daily amlodipine dose. At each blood draw, the patient will also use a breast pump to express breast milk for paired analysis. Both blood and breast milk amlodipine levels will be calculated for all samples. The levels will be used to determine the pharmacokinetics of amlodipine in the peri- and postpartum patient, including concentrations in plasma and breast milk.
In addition to collecting maternal data, a range of clinical information will be collected on each study patient's infant including weight, Apgar scores, hemodynamic parameters, physical examination and hospital course. This information will be used to screen for any potential complications associated with infant exposure to amlodipine. An infant blood sample will also be obtained in conjunction with the routine neonatal blood collection that occurs at 1-2 days of postnatal life and this will be analyzed to determine serum amlodipine concentration in breastfeeding infants.
- Conditions
- Chronic Hypertension in Pregnancy
- Being tested
- Amlodipine besylate
- Keywords
- Amlodipine besylate, Breast milk, Pharmacokinetics, Chronic hypertension, Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amlodipine besylateDrug
Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women taking amlodipine | Experimental | Women already taking amlodipine besylate 5 mg for treatment of chronic hypertension in pregnancy who plan to breastfeed postpartum will be assigned to the single experimental arm. Receives: Drug: Amlodipine besylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve for Amlodipine in the Maternal Serum
The time to peak amlodipine concentration in the maternal serum in the peripartum period was be measured.
Measured: Maternal blood samples will be obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing
Time to Maximal Concentration in the Maternal Serum.
The time to reach maximal amlodipine concentration in the maternal serum in the peripartum period was measured.
Measured: Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing
Maximal Amlodipine Maternal Serum Concentration
The maximum concentration of amlodipine detected in the maternal serum in the peripartum period was measured.
Measured: Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing
Half-life of Amlodipine in Maternal Plasma
The half-life of amlodipine in the maternal plasma in the peripartum period was measured.
Measured: Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing
Clearance Rate of Plasma Amlodipine
The clearance rate of amlodipine from the maternal plasma was measured.
Measured: Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing
Drug Levels/Concentration in Cord Blood (Amlodipine Levels/Concentrations)
Maternal and cord blood amlodipine levels/concentrations will be determined.
Measured: Pair maternal blood sample and cord blood sample will draw within 1 hour of delivery
Amlodipine Concentration in Breastmilk
The concentration of amlodipine besylate was measured in breastmilk samples.
Measured: Breast milk samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing
Drug Level/Concentration in Infant Blood (Amlodipine Level/Concentration)
Infant amlodipine level/concentration will be determined.
Measured: Infant blood sample drawn at approximately 36 hours of life
Secondary outcomes (4)
Neonatal Birth Weight
The neonatal weight at birth was collected.
Measured: Neonatal weight at the time of birth.
Infant Gestational Age at Delivery.
The mean gestational age of infants born to mothers taking Amlodipine besylate 5 mg daily was collected.
Measured: Gestational age at the time of birth
Infant Length of Stay.
The length of stay of infants born to women taking amlodipine besylate will be collected.
Measured: Time from birth to hospital discharge
Major Infant Complications
Any major complications experienced by infants born to women taking amlodipine besylate including NICU admission, intraventricular hemorrhage, neonatal seizures, need for respiratory support and apnea were collected.
Measured: During neonatal hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionJul 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Hypertension in PregnancyStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Jamie Morgan, University of Texas Southwestern Medical Center
- Investigators
- Jamie L Morgan, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353806
- Sponsor's protocol ID
- 042014-059
- Other IDs
- UL1TR001105
- Status last verified
- Jan 2019
- First submitted
- 26 Jan 2015
- Last updated
- 6 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Amlodipine Besylate at Delivery and During Lactation
- ClinicalTrials.gov ID
- NCT02353806
- Acronym / sponsor ID
- 042014-059
- Conditions
- Chronic Hypertension in Pregnancy
- Keywords
- Amlodipine besylate, Breast milk, Pharmacokinetics, Chronic hypertension, Pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- Jan 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 3 Feb 2015 (estimated)
- Results
- Posted 6 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase IV prospective trial to collect and analyze information about the maternal pharmacokinetics of amlodipine besylate at the time of delivery and during postpartum lactation. The study will also evaluate amlodipine concentrations in the infants of breastfeeding mothers who are taking amlodipine besylate for treatment chronic hypertension.
Detailed description
We plan to evaluate the pharmacokinetics of amlodipine besylate at the time of delivery, to determine if transplacental passage of the drug occurs. We will also examine the drug kinetics in postpartum lactation to establish whether amlodipine is excreted into breast milk. The outcomes of interest are plasma concentration of amlodipine at delivery and the drug concentrations in blood and breast milk over a twenty-hour steady-state period following milk-supply establishment. Fifteen patients already taking 5 mg of amlodipine during pregnancy for the treatment of chronic hypertension will be recruited from the antepartum Obstetric Complications Clinic at Parkland Hospital. Only women who are breastfeeding will be eligible for the study. Patients who elect to participate in the study will continue their amlodipine 5 mg dosing through delivery and into the postpartum period. Maternal blood will be drawn within one hour of delivery and fetal cord blood collected at the time of delivery. Patients will then have blood drawn over a 24 hour period beginning on postpartum day 2 after delivery following administration of their once-daily amlodipine dose. At each blood draw, the patient will also use a breast pump to express breast milk for paired analysis. Both blood and breast milk amlodipine levels will be calculated for all samples. The levels will be used to determine the pharmacokinetics of amlodipine in the peri- and postpartum patient, including concentrations in plasma and breast milk.
In addition to collecting maternal data, a range of clinical information will be collected on each study patient's infant including weight, Apgar scores, hemodynamic parameters, physical examination and hospital course. This information will be used to screen for any potential complications associated with infant exposure to amlodipine. An infant blood sample will also be obtained in conjunction with the routine neonatal blood collection that occurs at 1-2 days of postnatal life and this will be analyzed to determine serum amlodipine concentration in breastfeeding infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women taking amlodipine | Experimental | Drug: Amlodipine besylateWomen already taking amlodipine besylate 5 mg for treatment of chronic hypertension in pregnancy who plan to breastfeed postpartum will be assigned to the single experimental arm. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18 years or older;
- Pregnant female
- Already taking amlodipine 5 mg for treatment of chronic hypertension in pregnancy;
- Hospitalized following routine term vaginal delivery or uncomplicated cesarean delivery
- Breastfeeding or breast and bottle-feeding their infant
Key exclusion criteria (3 listed)
- Known kidney disease
- Delivery complicated by chorioamnionitis, endometritis or postpartum hemorrhage
- Administration of greater than 5 mg of amlodipine in 24 hour period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amlodipine besylatePregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician. | Drug | Pregnant women taking amlodipine |
Primary outcome
Area Under the Curve for Amlodipine in the Maternal Serum
Time frame: Maternal blood samples will be obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing
The time to peak amlodipine concentration in the maternal serum in the peripartum period was be measured.
Time to Maximal Concentration in the Maternal Serum.
Time frame: Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing
The time to reach maximal amlodipine concentration in the maternal serum in the peripartum period was measured.
Maximal Amlodipine Maternal Serum Concentration
Time frame: Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing
The maximum concentration of amlodipine detected in the maternal serum in the peripartum period was measured.
Half-life of Amlodipine in Maternal Plasma
Time frame: Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing
The half-life of amlodipine in the maternal plasma in the peripartum period was measured.
Clearance Rate of Plasma Amlodipine
Time frame: Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing
The clearance rate of amlodipine from the maternal plasma was measured.
Drug Levels/Concentration in Cord Blood (Amlodipine Levels/Concentrations)
Time frame: Pair maternal blood sample and cord blood sample will draw within 1 hour of delivery
Maternal and cord blood amlodipine levels/concentrations will be determined.
Amlodipine Concentration in Breastmilk
Time frame: Breast milk samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing
The concentration of amlodipine besylate was measured in breastmilk samples.
Drug Level/Concentration in Infant Blood (Amlodipine Level/Concentration)
Time frame: Infant blood sample drawn at approximately 36 hours of life
Infant amlodipine level/concentration will be determined.
4 secondary outcomes
Neonatal Birth Weight
Time frame: Neonatal weight at the time of birth.
Infant Gestational Age at Delivery.
Time frame: Gestational age at the time of birth
Infant Length of Stay.
Time frame: Time from birth to hospital discharge
Major Infant Complications
Time frame: During neonatal hospitalization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie L Morgan, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amlodipine besylate in people with Chronic Hypertension in Pregnancy, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Curve for Amlodipine in the Maternal Serum (time frame: Maternal blood samples will be obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2019.