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Is Procardia XL 60 mg Q Daily Equivalent to 30 mg XL Given Twice Daily?
Phase 4 trial testing Procardia XL 30Mg in Hypertension in Pregnancy in 5 participants. Terminated before completion.
| Lead sponsor | Icahn School of Medicine at Mount Sinai |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 5 |
| Start date | 15 September 2018 |
| Primary completion | 20 February 2020 |
| Estimated completion | 20 February 2020 |
| Sites | 1 location across United States |
Icahn School of Medicine at Mount Sinai
Adults 18 to 55, female only, with Hypertension in Pregnancy or Hypertension in Postpartum. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Blood pressure reading
| Group | Value | 95% CI |
|---|---|---|
| Procardia XL 30 mg | 155 | ± 14 |
| Procardia XL 60 mg | 146 | ± 2 |
| Group | Value | 95% CI |
|---|---|---|
| Procardia XL 30 mg | 92 | ± 10 |
| Procardia XL 60 mg | 84 | ± 5 |
Survey to assess Frequency of side effects of nifedipine including peripheral edema (most common side effect, dose related), flushing, headache, dizziness, fatigue, constipation, nausea, and muscle cramps.
| Group | Value | 95% CI |
|---|---|---|
| Procardia XL 30 mg | 1 | |
| Procardia XL 60 mg | 2 |
Time frame: 24 hours. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Procardia XL 30 mg | Procardia XL 60 mg |
|---|---|---|---|
| Headache | Nervous system disorders | — | — |
| Fatigue | General disorders | — | — |
Data from ClinicalTrials.gov NCT03595982 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial.
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