Hydrochlorothiazide for Postpartum Hypertension

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Antonio Saad, M.D.

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: The University of Texas Medical Branch, Galveston

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing whether hydrochlorothiazide can help prevent or reduce high blood pressure in women who have given birth. The medication works by making you urinate more, which helps lower blood pressure. Hydrochlorothiazide is known for its effectiveness in lowering blood pressure.

Eligibility Criteria

This trial is for women aged 18-50 who had high blood pressure or preeclampsia during pregnancy. They must not need blood pressure meds at screening, can't be discharged with such meds, and shouldn't have kidney failure, sulfonamide allergy, pre-gestational diabetes, lactose intolerance or issues that prevent follow-up.

Inclusion Criteria

I am a woman aged 18 to 49.

I have been diagnosed with high blood pressure or preeclampsia during or after pregnancy.

Exclusion Criteria

I had diabetes before becoming pregnant.

I am on medication for high blood pressure.

You are unable to digest lactose, a sugar found in milk and dairy products.

Participant Groups

The study tests if Hydrochlorothiazide (HCTZ), a water pill, can prevent high blood pressure problems after birth compared to a placebo. Women will randomly receive either HCTZ or an inactive tablet to see which is better at preventing relapses of hypertension or preeclampsia postpartum.

Group I: Hydrochlorothiazide 50mg Tablet Active Control 1 Intervention

Hydrochlorothiazide 50 mg per os once daily as soon as the subjects can tolerate sips of water after delivery and for a total of fourteen days postpartum.

Group II: Placebo Tablet Placebo Group 1 Intervention

Placebo per os once daily as soon as the subjects can tolerate sips of water after delivery and for fourteen days postpartum

Hydrochlorothiazide is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Hydrochlorothiazide for:

• Edema
• Hypertension
• Nephrotic syndrome
• Nephritic syndrome
• Gouty arthritis
• Calcium nephrolithiasis

🇪🇺 Approved in European Union as Hydrochlorothiazide for:

• Essential hypertension
• Oedema

🇨🇦 Approved in Canada as Hydrochlorothiazide for:

• Mild to moderate hypertension
• Edema

🇯🇵 Approved in Japan as Hydrochlorothiazide for:

• Hypertension
• Edema

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Texas Medical Branch Galveston, TX

Luis Monsivais Galveston, TX

St. David's North Austin Medical Center Austin, TX

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston Lead Sponsor

References