Is Procardia XL 60 mg Q Daily Equivalent to 30 mg XL Given Twice Daily?

NCT03595982 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: GCO 18-0959
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Antihypertensive therapy has been used in pregnant patients antepartum to improve blood pressure (BP) elevation in cases of chronic hypertension, and postpartum for persistent hypertension after delivery in cases of gestational hypertension and preeclampsia, as well as for management of chronic hypertension. There is limited evidence regarding the precise BP level at which antihypertensive therapy is indicated during pregnancy for chronic hypertension. Treatment has been suggested in pregnant patients when systolic BP is ≥ 160 mmHg and at a lower diastolic BP threshold of 105 mm Hg, however some providers may initiate therapy at systolic BPs ≥ 150 mmHg. Nifedipine is a peripheral arterial vasodilator and an ideal first line antihypertensive agent due to its low maternal side-effect profile. It has been proven to be safe in pregnancy. Conventional nifedipine can be started at 10 mg twice daily with a maximum dose of 120 mg/d, but frequently extended release tablets are preferred due to steady blood pressure control with once daily administration. It is frequently used however as a twice daily dosing as many providers have noticed an increase in the BPs 12-24h from administration. Twice daily dosing might produce overlapping profiles that prevent elevation of BP at the time of the next administration and breakthrough elevations throughout the day in pregnant women. The aim of this study is to investigate the mean plasma levels and standard deviations of Procardia at 24h after Procardia XL is administered as a 60 mg daily dose and the mean plasma levels after it is given as a 30 mg twice-daily dose. This will be a pilot study for a future randomized control trial that will allow the researchers to determine whether 60 mg daily of Procardia XL is equivalent to 30 mg twice daily. Secondary outcome will be effective control of BP throughout the day (0h, 4h, 8h, 12h, 16h, 20h and 24h) defined as BPs below 160/105 as well as side effects of nifedipine as reported by patients.

Conditions

Hypertension in Pregnancy; Hypertension in Postpartum

Keywords

chronic hypertension; postpartum hypertension; preeclampsia; treatment; Procardia XL

Outcome Measures

Primary Outcomes (2)

• Procardia Plasma Level

  Procardia plasma level at 24 hours after Procardia administration

  at 24 hours

• Blood Pressure (Systolic/Diastolic)

  Blood pressure reading

  up to 24 hours

Secondary Outcomes (1)

• Survey of Side Effects

  up to 24 hours

Study Arms (2)

Procardia XL 30 mg

EXPERIMENTAL

Procardia XL 30 mg XL Q 12h - When a patient's BP is persistently elevated after a dose of 30 mg of Procardia XL, the dose is increased to 60 mg Procardia XL divided in 2 doses of 30 mg given 12h apart.

Drug: Procardia XL 30Mg

Procardia XL 60 mg

ACTIVE COMPARATOR

Procardia XL 60 mg Q 24h - When a patient's BP is persistently elevated after a dose of 30 mg of Procardia XL, the dose is increased to 60 mg Procardia given once a day.

Drug: Procardia XL 60Mg

Interventions

Procardia XL 30Mg DRUG

Procardia XL 30 mg XL Q 12h

Procardia XL 30 mg

Procardia XL 60Mg DRUG

Procardia XL 60 mg Q 24h

Procardia XL 60 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Antepartum or postpartum patients between the age of 18-55 requiring 60 mg of Procardia XL to control elevated blood pressures secondary to preeclampsia, gestational hypertension, or chronic hypertension.

You may not qualify if:

• All patients receiving other antihypertensive medication
• All patients with a contraindication to nifedipine: Hypersensitivity to nifedipine or other calcium -channel blocker, cardiogenic shock, concomitant administration with strong CYP34A inducers (rifampin, rifabutin, phenobarbital, phenytoin, carbamazepine, St Johns Wort) → significantly reduces nifedipine efficacy, impaired liver function→? Patients with hepatic impairment (liver cirrhosis) have a longer disposition half-life and higher bioavailability of nifedipine than healthy volunteers
• Patients over the age of 55

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (5)

• Manninen AK, Juhakoski A. Nifedipine concentrations in maternal and umbilical serum, amniotic fluid, breast milk and urine of mothers and offspring. Int J Clin Pharmacol Res. 1991;11(5):231-6.

  PMID: 1814844 BACKGROUND

• Clement S, Bowen-Wright H. Twenty-four hour action of insulin glargine (Lantus) may be too short for once-daily dosing: a case report. Diabetes Care. 2002 Aug;25(8):1479-80. doi: 10.2337/diacare.25.8.1479-a. No abstract available.

  PMID: 12145255 BACKGROUND

• Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.

  PMID: 24150027 BACKGROUND

• Berghella, V., Maternal-Fetal Evidence Based Guideline. Third Edition ed. Series in Maternal-Fetal Medicine, ed. G.C.D.R.a.D. Maulik. 2017, Boca Raton, FL: Taylor ans Francis Group, LLC.

  BACKGROUND

• Procardia XL [package insent}. Pfizer Labs, New York, NY, 2016. Available from: http://labeling.pfizer.com/ShowLabeling.aspx?id=542. Accessed Novemeber 12, 2017.

  BACKGROUND

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Pre-Eclampsia

Interventions

Nifedipine

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Melissa Chu Lam
• Organization: Icahn School of Medicine at Mount Sinai

melissachu.md@gmail.com

520-360-8807

Study Officials

• Melissa T Chu Lam, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maternal Fetal Medicine Fellow

Model Details: Depending on the group the person gets randomized into they will receive 60 mg of nifedipine at 0h vs 30 mg of nifedipine at 0h followed by 30 mg extra at 12h, These medications will be administered by a nurse or physician on the floor. After 12h and at the end of the 24h (plus or minus 30 min) a blood sample (2cc) with be obtained and sent to Mount Sinai Hospital to determine serum Procardia levels. This blood samples will be stored until this research study is finished and will be disposed after. A total of 20cc of blood will be obtained from each patient. Also the patient will take a survey of side effects of the BP medication. BPs will be measured Q 4h and documented at 0h, 4h, 8h, 12h, 16h, 20h and 24h (plus or minus 30 min)

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: July 23, 2018
• Study Start: September 15, 2018
• Primary Completion: February 20, 2020
• Study Completion: February 20, 2020
• Last Updated: June 30, 2022
• Results First Posted: June 30, 2022

Record last verified: 2022-06

Locations

US (1)