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NCT03595982 · ClinicalTrials.gov registry record · Phase 4
Is Procardia XL 60 mg Q Daily Equivalent to 30 mg XL Given Twice Daily?
A Phase 4 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Terminated
- Registry status
- Phase 4
- Development phase
- 5
- Enrollment target
NCT03595982 is a Phase 4 study that was terminated before completion, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 5 participants.
The verdict
NCT03595982, a Phase 4 study, was terminated before completion, sponsored by Icahn School of Medicine at Mount Sinai.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 5 participants
- Enrollment target
Study 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 pat
Interventions
- DRUG Procardia XL 30Mg
- DRUG Procardia XL 60Mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2018-09-15 |
| Est. Completion | 2020-02-20 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03595982
The ClinicalTrials.gov registry entry for NCT03595982 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Procardia XL 30Mg is the first listed.
NCT03595982 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03595982 about?
NCT03595982 is a clinical study titled "Is Procardia XL 60 mg Q Daily Equivalent to 30 mg XL Given Twice Daily?". 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 hype...
What is the current status of trial NCT03595982?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 5 participants. The study started on 2018-09-15. Estimated completion is 2020-02-20.
What interventions are being tested in trial NCT03595982?
The interventions under investigation include: Procardia XL 30Mg (DRUG), Procardia XL 60Mg (DRUG).
Who is sponsoring clinical trial NCT03595982?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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