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Anti-hypertensive
Chronic Hypertension and Pregnancy (CHAP) Project (CHAP Trial)
Phase 4
Waitlist Available
Led By Gary Cutter, PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months postpartum
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved
Summary
This trial will compare two blood pressure treatment strategies during pregnancy.
Eligible Conditions
- High Blood Pressure
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months postpartum
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months postpartum
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Composite Adverse Perinatal Outcome
Small for Gestational Age (Safety)
Secondary study objectives
Adherence to Treatment After Delivery
Composite of Maternal Death or Severe Cardiovascular Morbidity
Composite of Severe Neonatal Morbidities
+2 moreOther study objectives
5-min Apgar Score
Blood Transfusion
Bradycardia
+23 moreSide effects data
From 2022 Phase 4 trial • 2408 Patients • NCT022994143%
Foetal Death
1%
Preeclampsia
1%
Stillbirth
1%
General Event
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anti-hypertensive Therapy to Goal <140/90 mmHg
No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg
Awards & Highlights
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.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Anti-hypertensive therapy to goal <140/90 mmHgExperimental Treatment1 Intervention
Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used
Group II: No anti-hypertensive unless BP is severe (≥160/105 mmHgActive Control1 Intervention
Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anti-hypertensive therapy
2015
Completed Phase 4
~2410
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesOTHER
1,399 Previous Clinical Trials
2,457,791 Total Patients Enrolled
University of Tennessee Health Science CenterOTHER
48 Previous Clinical Trials
22,696 Total Patients Enrolled
University of Alabama at BirminghamLead Sponsor
1,651 Previous Clinical Trials
2,441,531 Total Patients Enrolled
Columbia UniversityOTHER
1,496 Previous Clinical Trials
2,761,661 Total Patients Enrolled
Drexel University College of MedicineOTHER
34 Previous Clinical Trials
1,564 Total Patients Enrolled
Rutgers, The State University of New JerseyOTHER
452 Previous Clinical Trials
67,171 Total Patients Enrolled
Lehigh Valley HospitalOTHER
24 Previous Clinical Trials
14,319 Total Patients Enrolled
Saint Peters University HospitalOTHER
5 Previous Clinical Trials
1,651 Total Patients Enrolled
Christiana Care Health ServicesOTHER
116 Previous Clinical Trials
201,735 Total Patients Enrolled
Washington University School of MedicineOTHER
1,999 Previous Clinical Trials
2,333,080 Total Patients Enrolled