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ACE Inhibitor and Diuretic

Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension (ACE Trial)

Phase 4
Waitlist Available
Led By Michal Fishel Bartal, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year postpartum
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group
Approved for 5 Other Conditions
All Individual Drugs Already Approved

Summary

This trial is testing a combined pill of two medications to help lower blood pressure in women who have high blood pressure after giving birth. The pill works by relaxing blood vessels and removing extra salt and water from the body. The goal is to see if this combined pill is more effective than the usual treatment.

Eligible Conditions
  • Postpartum preeclampsia
  • Hypertension

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year postpartum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Stage 2 Hypertension
Secondary study objectives
Compliance With Medications
Incidence of Persistent Postpartum Hypertension
Number of Participants Who Received Additional Antihypertensive During Admission
+17 more

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.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Hctz/LisinoprilExperimental Treatment1 Intervention
Hctz/Lisinopril for postpartum management of hypertension. either a combined pill of ACE inhibitors and diuretics (Hydrochlorothiazide/Lisinopril)
Group II: Extended release nifedipineActive Control1 Intervention
calcium channel blocker (Nifedipine

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
957 Previous Clinical Trials
347,986 Total Patients Enrolled
Michal Fishel Bartal, MDPrincipal InvestigatorUT Health Science Center
2 Previous Clinical Trials
924 Total Patients Enrolled

Media Library

Hydrochlorothiazide/Lisinopril (ACE Inhibitor and Diuretic) Clinical Trial Eligibility Overview. Trial Name: NCT05049616 — Phase 4
Pre-eclampsia Research Study Groups: Hctz/Lisinopril, Extended release nifedipine
Pre-eclampsia Clinical Trial 2023: Hydrochlorothiazide/Lisinopril Highlights & Side Effects. Trial Name: NCT05049616 — Phase 4
Hydrochlorothiazide/Lisinopril (ACE Inhibitor and Diuretic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05049616 — Phase 4
~17 spots leftby Dec 2025
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