Study Summary
This trial is testing if amlodipine is just as effective as nifedipine ER in managing hypertension in postpartum women.
- Pregnancy-Induced Hypertension (PIH)
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: Through hospital stay, on average 2-5 days
Trial Safety
Phase-Based Safety
Side Effects for
Awards & Highlights
Trial Design
2 Treatment Groups
Nifedipine ER
1 of 2
Amlodipine
1 of 2
Active Control
Experimental Treatment
132 Total Participants · 2 Treatment Groups
Primary Treatment: Amlodipine · No Placebo Group · Phase 4
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · Female Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- “Hypertension in Pregnancy”. 2013. “Hypertension in Pregnancy”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.aog.0000437382.03963.88.
- Sharma, Kathryn J., Naomi Greene, and Sarah J. Kilpatrick. 2016. “Oral Labetalol Compared to Oral Nifedipine for Postpartum Hypertension: A Randomized Controlled Trial”. Hypertension in Pregnancy. Informa UK Limited. doi:10.1080/10641955.2016.1231317.
- “Acog”. 2019. “Acog”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aog.0000000000003018.
- “ACOG Practice Bulletin No. 203: Chronic Hypertension in Pregnancy”. 2019. “ACOG Practice Bulletin No. 203: Chronic Hypertension in Pregnancy”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aog.0000000000003020.
- Magee L, von Dadelszen P. Prevention and treatment of postpartum hypertension. Cochrane Database Syst Rev. 2013 Apr 30;(4):CD004351. doi: 10.1002/14651858.CD004351.pub3. Review.
- Cairns, Alexandra E, Louise Pealing, James M N Duffy, Nia Roberts, Katherine L Tucker, Paul Leeson, Lucy H MacKillop, and Richard J McManus. 2017. “Postpartum Management of Hypertensive Disorders of Pregnancy: A Systematic Review”. BMJ Open. BMJ. doi:10.1136/bmjopen-2017-018696.
- Hosie, James, Douglas Bremner, Peter J. Fell, Ian G.V. James, Peter A. Saul, and Stanley H. Taylor. 1992. “Comparison of Early Side Effects with Amlodipine and Nifedipine Retard in Hypertension”. Cardiology. S. Karger AG. doi:10.1159/000175048.
- Naito, Takafumi, Naoko Kubono, Shuhei Deguchi, Masahisa Sugihara, Hiroaki Itoh, Naohiro Kanayama, and Junichi Kawakami. 2014. “Amlodipine Passage into Breast Milk in Lactating Women with Pregnancy-induced Hypertension and Its Estimation of Infant Risk for Breastfeeding”. Journal of Human Lactation. SAGE Publications. doi:10.1177/0890334414560195.
- Ainuddin, Jahanara, Fariha Javed, and Sarah Kazi. 2019. “Oral Labetalol Versus Oral Nifedipine for the Management of Postpartum Hypertension a Randomized Control Trial”. Pakistan Journal of Medical Sciences. Pakistan Journal of Medical Sciences. doi:10.12669/pjms.35.5.812.
- 8. Bloch, M. (2020). In Basile J. (Ed.), Major side effects and safety of calcium channel blockers. UpToDate.
- Sharma, Kathryn J., Naomi Greene, and Sarah J. Kilpatrick. 2016. “Oral Labetalol Compared to Oral Nifedipine for Postpartum Hypertension: A Randomized Controlled Trial”. Hypertension in Pregnancy. Informa UK Limited. doi:10.1080/10641955.2016.1231317.
- 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.
- Cairns AE, Pealing L, Duffy JMN, Roberts N, Tucker KL, Leeson P, MacKillop LH, McManus RJ. Postpartum management of hypertensive disorders of pregnancy: a systematic review. BMJ Open. 2017 Nov 28;7(11):e018696. doi: 10.1136/bmjopen-2017-018696.
- Magee L, von Dadelszen P. Prevention and treatment of postpartum hypertension. Cochrane Database Syst Rev. 2013 Apr 30;(4):CD004351. doi: 10.1002/14651858.CD004351.pub3.
- Hosie J, Bremner AD, Fell PJ, James IG, Saul PA, Taylor SH. Comparison of early side effects with amlodipine and nifedipine retard in hypertension. Cardiology. 1992;80 Suppl 1:54-9. doi: 10.1159/000175048.
- 2021. "Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04790279.
Frequently Asked Questions
Could Amlodipine lead to adverse outcomes in individuals taking it?
"As this is a Phase 4 trial and thus widely approved, the safety of Amlodipine registers at 3 on our team's scale." - Anonymous Online Contributor
How many participants are currently enrolled in this research endeavor?
"Affirmative. Clinicaltrial.gov's records demonstrate that this scientific experiment is actively searching for participants, with recruitment beginning on April 11th 2021 and being updated most recently on September 26th 2022. This initiative requires 132 individuals to be sourced from one medical facility." - Anonymous Online Contributor
Is this a pioneering research endeavor?
"Presently, Amlodipine is being studied in 39 distinct trials across 194 cities and 24 nations. This research first began with a Phase 2 clinical trial sponsored by Encysive Pharmaceuticals back in 2007 which included 27 participants. Since then, 389 studies have been carried out on the topic." - Anonymous Online Contributor
What indications does Amlodipine usually address?
"Amlodipine is conventionally prescribed to halt premature labour, but also has a role in treating pulmonary hypertension and anal fissures. Additionally, it can be employed if dietary changes fail to make an impact on certain conditions." - Anonymous Online Contributor
Is enrollment currently available for this clinical trial?
"Indeed, the information on clinicaltrials.gov suggests that enrollment is now open for this medical trial. It was first publicized in April 2021 and has been recently updated on September 26th 2022. A total of 132 individuals are expected to take part from a single location." - Anonymous Online Contributor
What other scientific investigations have been undertaken with Amlodipine?
"Presently, Amlodipine is being test in 392 clinical trials with 9 of those studies at the Phase 3 level. Of these locations, a notable amount are based in Boston, Massachusetts while the rest are dispersed across different parts of the globe." - Anonymous Online Contributor