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Phase 4 Clinical Trials

Phase 4 trials (post-market surveillance) occur after a drug has been approved. They monitor long-term effectiveness and safety in general patient populations.

Total Trials
332
Recruiting Now
332
Top Conditions in Phase 4
Heart Failure (5) Breast Cancer (5) Pain, Postoperative (5) Cardiovascular Diseases (4) Diabetes Mellitus, Type 2 (4) Hypertension (4) Coronary Arterial Disease (CAD) (4) Crohn Disease (4) Surgery (3) Dexmedetomidine (3)

Frequently Asked Questions — Phase 4 Trials

What is the purpose of a Phase 4 post-market clinical trial?
Phase 4 trials occur after a drug has received regulatory approval. They monitor long-term effectiveness and safety in real-world patient populations, detect rare adverse events too infrequent to appear in earlier trials, study effectiveness in subgroups (elderly, pediatric, renally impaired), and may explore new indications for the approved drug. Some Phase 4 studies are mandated by the FDA as a condition of approval.
Who sponsors Phase 4 trials?
Phase 4 trials are primarily sponsored by pharmaceutical and biotech companies that hold the drug's marketing authorization. Some are mandated by the FDA or EMA—particularly when approval was based on surrogate endpoints and confirmatory long-term data is required. Independent academic institutions and registry-based programs also conduct Phase 4 studies.
Are Phase 4 trials safer than Phase 1–3 trials?
Phase 4 trials involve drugs that have already demonstrated an acceptable safety profile in earlier phases and received regulatory approval. As a result, the risk profile for participants is generally better characterized than in early-phase trials. However, these studies are still clinical research designed partly to detect long-term or rare adverse events not observed in pre-approval trials.

Active Phase 4 Studies

NCT04899479 Phase 4
Recruiting
Peri-treatment of SGLT-2 Inhibitor on Myocardial Infarct Size and Remodeling Ind...
Condition
Acute Myocardial Infarction
Enrollment
200 pts
Location
South Korea
Sponsor
Samsung Medical Center
View Trial →
NCT06468202 Phase 4
Recruiting
Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of P...
Condition
Hypertensive Disorders of Pregnancy
Enrollment
10,742 pts
Location
United States
Sponsor
Ohio State University
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NCT07023094 Phase 4
Recruiting
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Condition
Hip Disease
Enrollment
60 pts
Location
Poland
Sponsor
Poznan University of Medical S
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NCT06384651 Phase 4
Recruiting
Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplas...
Condition
Infections
Enrollment
40 pts
Location
United States
Sponsor
The Methodist Hospital Researc
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NCT06248229 Phase 4
Recruiting
A Trial of Dyanavel XR in Treating Co-occurring Fatigue Symptoms in Adults With ...
Condition
Fatigue
Enrollment
50 pts
Location
United States
Sponsor
Rochester Center for Behaviora
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NCT07322237 Phase 4
Recruiting
DICE Study- Diastolic Improvement With Carvedilol & Empagliflozin in Patients Wi...
Condition
Cirrhotic Cardiomyopathy
Enrollment
400 pts
Location
India
Sponsor
Post Graduate Institute of Med
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NCT06855537 Phase 4
Recruiting
Effectiveness of Interventional Therapy for Non-Flow-Limiting Vulnerable Plaques
Condition
Coronary Arterial Disease (CAD)
Enrollment
2,190 pts
Location
China
Sponsor
Beijing Anzhen Hospital
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NCT06478186 Phase 4
Recruiting
Knee Osteoarthritis Treatment With Zilretta vs. Kenalog in the Context of Type I...
Condition
Osteoarthritis, Knee
Enrollment
120 pts
Location
United States
Sponsor
University of Kansas Medical C
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NCT07762170 Phase 4
Recruiting
Success Rates and Safety of Steroid Injections in Managing Spinal and Sacro-Ilia...
Condition
Back Pain Lower Back
Enrollment
500 pts
Location
Canada
Sponsor
Igor Wilderman. MD
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NCT05004987 Phase 4
Recruiting
Aβ Dynamics in LLMD
Condition
Alzheimer Disease
Enrollment
60 pts
Location
United States
Sponsor
NYU Langone Health
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NCT07172893 Phase 4
Recruiting
A Non-Randomized Open Label Clinical Trial Evaluating DermaBind TL
Condition
Diabetic Foot Ulcer (DFU)
Enrollment
150 pts
Location
United States
Sponsor
HealthTech Wound Care
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NCT06966635 Phase 4
Recruiting
Exploratory Study on the Treatment of Gout With Potassium Citrate Sustained-rele...
Condition
Hyperuricemia or Gout
Enrollment
312 pts
Location
China
Sponsor
Huashan Hospital
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NCT06613178 Phase 4
Recruiting
Intravenous Acetaminophen After Cardiac Surgery - Definitive Study
Condition
Post Operative Delirium
Enrollment
1,100 pts
Location
Canada
Sponsor
McGill University Health Centr
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NCT05746143 Phase 4
Recruiting
The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion
Condition
Spine Fusion
Enrollment
140 pts
Location
United States
Sponsor
University of Southern Califor
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NCT06055452 Phase 4
Recruiting
Effects of SGLT2 Inhibitors in Pre-heart Failure Populations With Hypertension
Condition
Pre-Heart Failure
Enrollment
120 pts
Location
China
Sponsor
China National Center for Card
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NCT05838287 Phase 4
Recruiting
Pioglitazone on Heart Failure in Type-2 Diabetes Mellitus Participants
Condition
Type 2 Diabetes Mellitus in Obese
Enrollment
78 pts
Location
United States
Sponsor
The University of Texas Health
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NCT06873321 Phase 4
Recruiting
VTE Incidence After Rivaroxaban + Aspirin or SAPT After Lower-limb Revasculariza...
Condition
Peripheral Arterial Disease
Enrollment
100 pts
Location
Brazil
Sponsor
Science Valley Research Instit
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NCT06420258 Phase 4
Recruiting
Deeper Intubation Make Effects on Cervical Esophageal ESD
Condition
Carcinoma in Situ of Cervical Part of Esophagus
Enrollment
40 pts
Location
China
Sponsor
Fujian Provincial Hospital
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NCT07156084 Phase 4
Recruiting
Persistence of Immune Response Six Years After One Dose of 9vHPV Vaccine Among M...
Condition
HPV Vaccine
Enrollment
300 pts
Location
Canada
Sponsor
Canadian Immunization Research
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NCT07423247 Phase 4
Recruiting
Tirzepatide (Spartina) in Obese Kidney Transplant Recipients
Condition
Tirzepatide
Enrollment
30 pts
Location
Iran
Sponsor
Shahid Beheshti University of
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NCT07247058 Phase 4
Recruiting
Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)
Condition
Mild Autonomous Cortisol Secretion (MACS)
Enrollment
10 pts
Location
United States
Sponsor
Johns Hopkins University
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NCT07707063 Phase 4
Recruiting
This a Clinical Trial to Evaluate the Efficacy of I-PRF, Povidone-Iodine and Las...
Condition
Periodontitis
Enrollment
50 pts
Location
Tunisia
Sponsor
Military Hospital of Tunis
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NCT07087106 Phase 4
Recruiting
Glucose Consumption in MS Using [F-18]FDG-PET
Condition
Multiple Sclerosis
Enrollment
50 pts
Location
United States
Sponsor
Brigham and Women's Hospital
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NCT06108648 Phase 4
Recruiting
Efficacy of Lavender Essential Oil Chest Wraps in Infants With Bronchiolitis
Condition
Bronchiolitis
Enrollment
400 pts
Location
Switzerland
Sponsor
University Hospital, Geneva
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NCT05051436 Phase 4
Recruiting
The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics
Condition
Pre-diabetes
Enrollment
96 pts
Location
United States
Sponsor
Philip Kern
View Trial →
Page 4 of 14 — 332 trials total
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