Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04967443 · ClinicalTrials.gov registry record · Phase 1
Pivotal Bioequivalence Study to Qualify Manufacturing Site Transfer for Prazosin Hydrochloride Capsules
A Phase 1 study of Hypertension and Heart Failure, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT04967443: Completed Phase 1 study of Hypertension and Heart Failure, sponsored by Pfizer.
NCT04967443 is a Phase 1 study of Hypertension and Heart Failure that has completed, run by Pfizer. The registered enrollment target is 72 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04967443, a Phase 1 study of Hypertension and Heart Failure, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study Summary
Prazosin hydrochloride (HCl) is an oral anti-hypertensive indicated for the treatment of primary and secondary hypertension and heart failure. Pfizer Inc. is the marketing authorization holder for prazosin HCl oral capsules and intended to transfer drug product manufacturing operations from Pfizer, Barceloneta Puerto Rico to Pfizer Pharmaceutical, Ascoli, Italy. To support the manufacturer site transfer and process changes, this bioequivalence (BE) study is being conducted. This study will be a 2 Cohort, open-label, randomized, single dose study in healthy adult male and/or female participants. Cohort 1 will be crossover with 3 treatments, 3 periods, 6 sequences. Cohort 2 will be crossover with 2 treatments, 2 periods, 2 sequences. Primary objective of this study is demonstrate bioequivalence between prazosin HCl 1, 2 and 5 mg capsules manufactured at Ascoli versus prazosin HCl 2 and 5 mg capsules manufactured at Barceloneta under fasting conditions in healthy adult participants. Approximately 36 participants will be enrolled in each Cohort 1 and Cohort 2. Pharmacokinetic and statistical analysis will be performed for prazosin. Data from 2 Cohorts will be analyzed separately. The PK parameters area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast), and from time zero extrapolated to infinite time (AUCinf), maximum plasma concentration (Cmax), time to first occurrence of Cmax (Tmax), and terminal phase elimination half-life (t½) will be summarized descriptively by analyte and treatment. For primary objective, bioequivalence of the Test treatment relative to Reference treatment will be concluded if the 90% confidence intervals (CI) for the ratio of adjusted geometric means of Test treatments relative to Reference treatment for AUCinf (if data permit), AUClast and Cmax, fall wholly within (80%, 125%).
Conditions Studied
Interventions
- DRUG Prazosin HCl 2mg
- DRUG Prazosin HCl 1 mg
- DRUG Prazosin HCl 5 mg
Study Locations (1)
Texas
- Clinical Trials of Texas, LLC - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2021-09-22 |
| Est. Completion | 2022-02-15 |
| Phase | Phase 1 |
What the finished NCT04967443 record still lists
NCT04967443 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Hypertension appearing as the primary indexed condition, and to 3 interventions - of which Prazosin HCl 2mg is the first listed.
NCT04967443 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04967443 about?
NCT04967443 is a clinical study titled "Pivotal Bioequivalence Study to Qualify Manufacturing Site Transfer for Prazosin Hydrochloride Capsules". Prazosin hydrochloride (HCl) is an oral anti-hypertensive indicated for the treatment of primary and secondary hypertension and heart failure. Pfizer Inc. is the marketing authorization holder for prazosin HCl oral capsules and intended to transfer drug product manufacturing operations from Pfizer, ...
What is the current status of trial NCT04967443?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2021-09-22. Estimated completion is 2022-02-15.
What conditions does trial NCT04967443 study?
This clinical trial studies the following conditions: Hypertension, Heart Failure.
What interventions are being tested in trial NCT04967443?
The interventions under investigation include: Prazosin HCl 2mg (DRUG), Prazosin HCl 1 mg (DRUG), Prazosin HCl 5 mg (DRUG).
Who is sponsoring clinical trial NCT04967443?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04967443 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hypertension
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04967443's enrollment target sits among peer trials
72 330th of 470 higher than 139 of 470 other Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study of LY3971297 in Healthy Participants
RECRUITING · Phase 1
-
Metabolic Effects of Angiotensin-(1-7)
RECRUITING · Phase 1
-
Sympathetic Mechanisms in Obesity-Crossover Design
RECRUITING · Phase 1
-
Targeting Endoplasmic Reticulum Stress in Human Hypertension
RECRUITING · Phase 1
-
: Vascular Function in Health and Disease
RECRUITING · Phase 1
-
Sympathetic-vascular Dysfunction in Obesity and Insulin Resistance (Vitamin C Study)
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02359253 · 72 participants · NA
Robot Aided Rehabilitation - Intervention
- NCT02962661 · 72 participants · Phase 1
Donor Bone Marrow Derived Mesenchymal Stem Cells in Controlling Heart Failure in Patients With Cardiomyopathy Caused by Anthracyclines
- NCT03113643 · 72 participants · Phase 1
SL-401 in Combination With Azacitidine or Azacitidine/Venetoclax in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
- NCT03187535 · 72 participants · NA
Effect of TEAS on PONV After Spinal Surgery
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI