Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pharmacokinetics of Amlodipine Besylate at Delivery and During Lactation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02353806
Recruitment Status : Completed
First Posted : February 3, 2015
Results First Posted : February 6, 2019
Last Update Posted : February 6, 2019
Sponsor:
Collaborator:
National Center for Advancing Translational Science (NCATS)
Information provided by (Responsible Party):
Jamie Morgan, University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Hypertension in Pregnancy
Intervention Drug: Amlodipine besylate
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pregnant Women Taking Amlodipine
Hide Arm/Group Description

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.

Amlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.

Period Title: Overall Study
Started 16
Completed 6
Not Completed 10
Arm/Group Title Pregnant Women Taking Amlodipine
Hide Arm/Group Description

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.

Amlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.

Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
33.2  (5.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
16
 100.0%
Male NA [1] 
[1]
This study only included pregnant women.
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Black or African American
3
  18.8%
Hispanic
12
  75.0%
Other
1
   6.3%
1.Primary Outcome
Title Area Under the Curve for Amlodipine in the Maternal Serum
Hide Description The time to peak amlodipine concentration in the maternal serum in the peripartum period was be measured.
Time Frame Maternal blood samples will be obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Although 16 women were enrolled in the study, only 11 of the 16 had blood drawn at the time of delivery. This was due to limitations of study personnel availability to attend the deliveries of all study patients
Arm/Group Title Pregnant Women Taking Amlodipine
Hide Arm/Group Description:

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.

Amlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.

Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: (hr*ng)/mL
53.4  (19.8)
2.Primary Outcome
Title Time to Maximal Concentration in the Maternal Serum.
Hide Description The time to reach maximal amlodipine concentration in the maternal serum in the peripartum period was measured.
Time Frame Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Although 16 women were enrolled in the trial, only 11 had their blood drawn at the time of delivery due to limited availability of study personnel.
Arm/Group Title Pregnant Women Taking Amlodipine
Hide Arm/Group Description:

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.

Amlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.

Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: Hours
7.5  (1.5)
3.Primary Outcome
Title Maximal Amlodipine Maternal Serum Concentration
Hide Description The maximum concentration of amlodipine detected in the maternal serum in the peripartum period was measured.
Time Frame Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Although 16 women were enrolled in the trial, only 11 had their blood drawn at the time of delivery due to limited availability of study personnel.
Arm/Group Title Pregnant Women Taking Amlodipine
Hide Arm/Group Description:

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.

Amlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.

Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: ng/mL
2.0  (1.0)
4.Primary Outcome
Title Half-life of Amlodipine in Maternal Plasma
Hide Description The half-life of amlodipine in the maternal plasma in the peripartum period was measured.
Time Frame Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregnant Women Taking Amlodipine
Hide Arm/Group Description:

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.

Amlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.

Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: Hours
13.7  (4.9)
5.Primary Outcome
Title Clearance Rate of Plasma Amlodipine
Hide Description The clearance rate of amlodipine from the maternal plasma was measured.
Time Frame Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Although 16 women were enrolled in the trial, only 11 had their blood drawn at the time of delivery due to limited availability of study personnel.
Arm/Group Title Pregnant Women Taking Amlodipine
Hide Arm/Group Description:

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.

Amlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.

Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: L/hr
109.7  (58.9)
6.Primary Outcome
Title Drug Levels/Concentration in Cord Blood (Amlodipine Levels/Concentrations)
Hide Description Maternal and cord blood amlodipine levels/concentrations will be determined.
Time Frame Pair maternal blood sample and cord blood sample will draw within 1 hour of delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregnant Women Taking Amlodipine
Hide Arm/Group Description:

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.

Amlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.

Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: ng/mL
Infant cord blood plasma amlodipine concentration 0.49  (0.29)
Maternal serum amlodipine concentration 1.27  (0.84)
7.Primary Outcome
Title Amlodipine Concentration in Breastmilk
Hide Description The concentration of amlodipine besylate was measured in breastmilk samples.
Time Frame Breast milk samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregnant Women Taking Amlodipine
Hide Arm/Group Description:

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.

Amlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.

Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: ng/mL
NA [1]   (NA)
[1]
Amlodipine concentrations in maternal breast milk were undetectable at the lower limit of assay detection (<0.1 ng/mL).
8.Primary Outcome
Title Drug Level/Concentration in Infant Blood (Amlodipine Level/Concentration)
Hide Description Infant amlodipine level/concentration will be determined.
Time Frame Infant blood sample drawn at approximately 36 hours of life
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 16 patients enrolled in the study, only 8 continued in the study and allowed their infant's to have study sampling performed.
Arm/Group Title Pregnant Women Taking Amlodipine
Hide Arm/Group Description:

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.

Amlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: ng/mL
NA [1]   (NA)
[1]
Amlodipine concentrations in infant plasma were undetectable at the lower limit of assay detection (<0.1 ng/mL)
9.Secondary Outcome
Title Neonatal Birth Weight
Hide Description The neonatal weight at birth was collected.
Time Frame Neonatal weight at the time of birth.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infant's Born to Women Taking Amlodipine Besylate
Hide Arm/Group Description:

Infant's born to women already taking amlodipine besylate 5 mg for the treatment of chronic hypertension in pregnancy and who planned to breastfeed their babies.

Amlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.

Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: grams
3281  (525)
10.Secondary Outcome
Title Infant Gestational Age at Delivery.
Hide Description The mean gestational age of infants born to mothers taking Amlodipine besylate 5 mg daily was collected.
Time Frame Gestational age at the time of birth
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infant's Born to Women Taking Amlodipine Besylate
Hide Arm/Group Description:
Infant's born to women already taking amlodipine besylate 5 mg for the treatment of chronic hypertension in pregnancy and who planned to breastfeed their babies.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: weeks
38.2  (0.8)
11.Secondary Outcome
Title Infant Length of Stay.
Hide Description The length of stay of infants born to women taking amlodipine besylate will be collected.
Time Frame Time from birth to hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infant's Born to Women Taking Amlodipine Besylate
Hide Arm/Group Description:

Infant's born to women already taking amlodipine besylate 5 mg for the treatment of chronic hypertension in pregnancy and who planned to breastfeed their babies.

Amlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.

Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Days
3.6  (0.5)
12.Secondary Outcome
Title Major Infant Complications
Hide Description 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.
Time Frame During neonatal hospitalization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infant's Born to Women Taking Amlodipine Besylate
Hide Arm/Group Description:

Infant's born to women already taking amlodipine besylate 5 mg for the treatment of chronic hypertension in pregnancy and who planned to breastfeed their babies.

Amlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.

Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: Participants
Admission to the NICU 0
Major neonatal complications (IVH, apnea, seizure) 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pregnant Women Taking Amlodipine
Hide Arm/Group Description

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.

Amlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.

All-Cause Mortality
Pregnant Women Taking Amlodipine
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Pregnant Women Taking Amlodipine
Affected / at Risk (%)
Total   0/16 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pregnant Women Taking Amlodipine
Affected / at Risk (%)
Total   0/16 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jamie Morgan, MD
Organization: University of Texas Southwestern Medical Center
Phone: 214-645-3838 ext 2147665011
EMail: jamie.morgan@utsouthwestern.edu
Layout table for additonal information
Responsible Party: Jamie Morgan, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02353806    
Other Study ID Numbers: 042014-059
UL1TR001105 ( U.S. NIH Grant/Contract )
First Submitted: January 26, 2015
First Posted: February 3, 2015
Results First Submitted: November 28, 2018
Results First Posted: February 6, 2019
Last Update Posted: February 6, 2019