Amlodipine for Hypertension

Greenville Memorial Hospital, Greenville, SC
HypertensionAmlodipine - Drug
Eligibility
18+
Female
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Study Summary

This trial is testing if amlodipine is just as effective as nifedipine ER in managing hypertension in postpartum women.

Eligible Conditions
  • Pregnancy-Induced Hypertension (PIH)

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

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Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Through hospital stay, on average 2-5 days

Day 5
Length of stay
Antihypertensive Agents
Number of patients discontinuing medication due to side effects
Number of side effects reported by patient
until 6 weeks postpartum
Breastfeeding duration
Number of patients reporting satisfaction with breastfeeding experience on patient-completed questionnaire
Number of patients requiring hospital readmission

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Progesterone Arm
1
ICG
1
Eculizumab

Side Effects for

Aim 1- Low Sodium
7%Headache
4%viral illness
4%numbness
4%Low glucose
4%Dizziness/Lightheadedness
4%Nausea
This histogram enumerates side effects from a completed 2019 Phase 4 trial (NCT02034435) in the Aim 1- Low Sodium ARM group. Side effects include: Headache with 7%, viral illness with 4%, numbness with 4%, Low glucose with 4%, Dizziness/Lightheadedness with 4%.

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.

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

Amlodipine
Drug
Experimental Group · 1 Intervention: Amlodipine · Intervention Types: Drug
Nifedipine ER
Drug
ActiveComparator Group · 1 Intervention: NIFEdipine ER · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amlodipine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through hospital stay, on average 2-5 days

Who is running the clinical trial?

Prisma Health-UpstateLead Sponsor
75 Previous Clinical Trials
42,486 Total Patients Enrolled
1 Trials studying Hypertension
202 Patients Enrolled for Hypertension

Eligibility Criteria

Age 18+ · Female Participants · 5 Total Inclusion Criteria

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References

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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