Is Procardia XL 60 mg Q Daily Equivalent to 30 mg XL Given Twice Daily?
Status:
Terminated
Trial end date:
2020-02-20
Target enrollment:
Participant gender:
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.