Hypertension in PregnancyPhase 4NCT03595982
Is Procardia XL 60 mg Q Daily Equivalent to 30 mg XL Given Twice Daily?
A Phase 4 study testing Procardia XL 30Mg and Procardia XL 60Mg in people with Hypertension in Pregnancy and Hypertension in Postpartum, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Hypertension in Pregnancy, Hypertension in Postpartum
- What is being tested?
- Procardia XL 30Mg and Procardia XL 60Mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2018to 20 Feb 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
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.
Read more
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.
Read the detailed description
There is limited evidence regarding the precise BP level at which antihypertensive therapy is indicated during pregnancy for chronic hypertension. Given the limitations of data as well as higher likelihood of outpatient therapy with less frequent blood pressure monitoring, 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.
Antihypertensive therapy has not been shown to improve fetal condition or to prevent preeclampsia. However, such therapy controls acceleration of BP, reduces antepartum hospitalization due to severe hypertension and should help prevent maternal complications from uncontrolled hypertension such as cardiovascular (congestive heart failure and myocardial ischemia), renal (renal injury or failure), or cerebrovascular (ischemic or hemorrhagic stroke) damage.
Drugs such as methyldopa, labetalol, and nifedipine in many occasions are used as first line agents for control of hypertension in pregnancy.
Calcium channel blockers are a class of drugs that have not been extensively studied in pregnant women with chronic hypertension, however they are still considered standard of care for treatment of elevated BPs during pregnancy and after delivery. Small amounts have been shown to cross the placenta, however to date no known association with birth defects have been found with reassuring long term follow-up of babies up to 1.5 years. It is not associated with adverse perinatal outcomes and furthermore, nifedipine does not appear to adversely affect uterine or umbilical blood flow.
Nifedipine is a peripheral arterial vasodilator and an ideal first line antihypertensive agent due to its low maternal side-effect profile. 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. The extended release tablet consists of a semipermeable membrane surrounding an osmotically active drug core and has been designed to provide nifedipine an approximately constant rate over 24h.
- Being tested
- Procardia XL 30Mg, Procardia XL 60Mg
- Keywords
- chronic hypertension, postpartum hypertension, preeclampsia, treatment, Procardia XL
- Medical subject headings
- Hypertension, Pregnancy-Induced, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procardia XL 30MgDrug
Procardia XL 30 mg XL Q 12h
Procardia XL 60MgDrug
Procardia XL 60 mg Q 24h
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Procardia XL 60Mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procardia Plasma Level
Procardia plasma level at 24 hours after Procardia administration
Measured: at 24 hours
Blood Pressure (Systolic/Diastolic)
Blood pressure reading
Measured: up to 24 hours
Secondary outcomes (1)
Survey of Side Effects
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.
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start15 Sep 2018
- Primary completion20 Feb 2020
- Study completion20 Feb 2020
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hypertension in PregnancyStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Chu Lam, Icahn School of Medicine at Mount Sinai
- Investigators
- Melissa T Chu Lam, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595982
- Sponsor's protocol ID
- GCO 18-0959
- Status last verified
- Jun 2022
- First submitted
- 11 Jul 2018
- Last updated
- 30 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 1814844Clement 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.
PubMed 12145255Hypertension 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.
PubMed 24150027Berghella, 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.
Procardia XL [package insent}. Pfizer Labs, New York, NY, 2016. Available from: http://labeling.pfizer.com/ShowLabeling.aspx?id=542. Accessed Novemeber 12, 2017.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Procardia XL 60 mg Q Daily Equivalent to 30 mg XL Given Twice Daily?
- ClinicalTrials.gov ID
- NCT03595982
- Acronym / sponsor ID
- GCO 18-0959
- Keywords
- chronic hypertension, postpartum hypertension, preeclampsia, treatment, Procardia XL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 23 Jul 2018 (actual)
- Results
- Posted 30 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There is limited evidence regarding the precise BP level at which antihypertensive therapy is indicated during pregnancy for chronic hypertension. Given the limitations of data as well as higher likelihood of outpatient therapy with less frequent blood pressure monitoring, 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.
Antihypertensive therapy has not been shown to improve fetal condition or to prevent preeclampsia. However, such therapy controls acceleration of BP, reduces antepartum hospitalization due to severe hypertension and should help prevent maternal complications from uncontrolled hypertension such as cardiovascular (congestive heart failure and myocardial ischemia), renal (renal injury or failure), or cerebrovascular (ischemic or hemorrhagic stroke) damage.
Drugs such as methyldopa, labetalol, and nifedipine in many occasions are used as first line agents for control of hypertension in pregnancy.
Calcium channel blockers are a class of drugs that have not been extensively studied in pregnant women with chronic hypertension, however they are still considered standard of care for treatment of elevated BPs during pregnancy and after delivery. Small amounts have been shown to cross the placenta, however to date no known association with birth defects have been found with reassuring long term follow-up of babies up to 1.5 years. It is not associated with adverse perinatal outcomes and furthermore, nifedipine does not appear to adversely affect uterine or umbilical blood flow.
Nifedipine is a peripheral arterial vasodilator and an ideal first line antihypertensive agent due to its low maternal side-effect profile. 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. The extended release tablet consists of a semipermeable membrane surrounding an osmotically active drug core and has been designed to provide nifedipine an approximately constant rate over 24h.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Procardia XL 30 mg | Experimental | Drug: Procardia XL 30MgProcardia 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. |
| Procardia XL 60 mg | Active comparator | Drug: Procardia XL 60MgProcardia 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Procardia XL 30MgProcardia XL 30 mg XL Q 12h | Drug | Procardia XL 30 mg |
| Procardia XL 60MgProcardia XL 60 mg Q 24h | Drug | Procardia XL 60 mg |
Primary outcome
Procardia Plasma Level
Time frame: at 24 hours
Procardia plasma level at 24 hours after Procardia administration
Blood Pressure (Systolic/Diastolic)
Time frame: up to 24 hours
Blood pressure reading
1 secondary outcome
Survey of Side Effects
Time frame: up to 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 1814844Manninen 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.
- Background: PubMed 12145255Clement 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.
- Background: PubMed 24150027Hypertension 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.
- BackgroundBerghella, 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.
- BackgroundProcardia XL [package insent}. Pfizer Labs, New York, NY, 2016. Available from: http://labeling.pfizer.com/ShowLabeling.aspx?id=542. Accessed Novemeber 12, 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa T Chu Lam, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Procardia XL 30Mg and Procardia XL 60Mg in people with Hypertension in Pregnancy and Hypertension in Postpartum, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procardia Plasma Level (time frame: at 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03595982, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.