HypertensionPhase 1NCT04967443

Pivotal Bioequivalence Study to Qualify Manufacturing Site Transfer for Prazosin Hydrochloride Capsules

A Phase 1 study testing Prazosin HCl 2mg, Prazosin HCl 1 mg and Prazosin HCl 5 mg in people with Hypertension and Heart Failure, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Hypertension, Heart Failure
What is being tested?: Prazosin HCl 2mg, Prazosin HCl 1 mg and Prazosin HCl 5 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteUnited States
Study dates: 22 Sep 2021to 15 Feb 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Participants must be 18 to 55 years of age, inclusive, at the time of signing the Informed Consent Document (ICD).
Male and female participants who are overtly healthy as determined by medical evaluation including medical history, full physical examination, vital signs, 12-lead electrocardiogram (ECG), and/or clinical laboratory tests.
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations , and other study procedures.
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Who cannot join

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
Any condition possibly affecting drug absorption (eg, gastrectomy).
History of Human Immunodeficiency Virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb) or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.
A positive urine drug test.
Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest.

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Baseline standard 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:
aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≥1.5 × upper limit of normal (ULN);
Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN.
History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
Use of tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes per day. For chewing tobacco, one chew is equivalent to approximately 2 to 3 cigarettes, so participants would be limited to 2 or less chews per day.
History of sensitivity to prazosin hydrochloride or any of the components in the formulation of the study products.

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinical Trials of Texas, LLC
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A 2 COHORT, SINGLE DOSE, OPEN-LABEL, RANDOMIZED, PIVOTAL BIOEQUIVALENCE STUDY TO QUALIFY MANUFACTURING SITE TRANSFER FROM BARCELONETA TO ASCOLI FOR PRAZOSIN HYDROCHLORIDE CAPSULES IN HEALTHY ADULT PARTICIPANTS UNDER FASTED CONDITIONS

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: Hypertension, Heart Failure
Being tested: Prazosin HCl 2mg, Prazosin HCl 1 mg, Prazosin HCl 5 mg
Medical subject headings: Hypertension, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prazosin HCl 2mgDrug
Also called Minipress 2 mg capsule.
Prazosin HCL 1 X 2 mg capsule.
Prazosin HCl 1 mgDrug
Also called Minipress 1 mg capsule.
Prazosin HCl 2 X 1 mg capsule.
Prazosin HCl 5 mgDrug
Also called Minipress 5 mg capsule.
Prazosin HCL 1 X 5 mg capsule.

Study groups in NCT04967443
Study group	Role	What they receive
Prazosin Hydrochloride (HCL) 2 milligram (mg) capsule Barceloneta site	Active comparator	One 2 mg capsule manufactured at the current site, Barceloneta Receives: Drug: Prazosin HCl 2mg
Prazosin HCL 2 mg capsule Ascoli site	Experimental	One 2 mg capsule manufactured at the proposed site (Ascoli) Receives: Drug: Prazosin HCl 2mg
Prazosin HCL 1 mg capsule Ascoli site	Experimental	Two 1 mg capsule manufactured at the proposed site, Ascoli Receives: Drug: Prazosin HCl 1 mg
Prazosin HCL 5 mg capsule Barceloneta site	Active comparator	One 5 mg capsule manufactured at the current site, Barceloneta Receives: Drug: Prazosin HCl 5 mg
Prazosin HCL 1 x 5 mg capsule Ascoli site	Active comparator	One 5 mg capsule manufactured at the proposed site, Ascoli Receives: Drug: Prazosin HCl 5 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Prazosin
Measured: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of each period
Maximum Observed Plasma Concentration (Cmax) of Prazosin
Measured: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of each period

Secondary outcomes (4)

Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Prazosin
Measured: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of each period
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Prazosin
Measured: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of each period
Plasma Decay Half-Life (t1/2) of Prazosin
Plasma terminal elimination half-life of Prazosin was measured.
Measured: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of each period
Number of Participants With Adverse Events (AEs) According to Seriousness
Adverse events (AEs): any untoward medical occurrence in a clinical investigation participant administered a product or medical device, without regard to causality. Treatment-emergent AEs (TEAEs): AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant.
Measured: Time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Sep 202115 Feb 2022

First posted19 Jul 2021
Study start22 Sep 2021
Primary completion15 Feb 2022
Study completion15 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04967443
Sponsor's protocol ID: A0281006
Status last verified: Jan 2024
First submitted: 8 Jul 2021
Last updated: 12 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 2 COHORT, SINGLE DOSE, OPEN-LABEL, RANDOMIZED, PIVOTAL BIOEQUIVALENCE STUDY TO QUALIFY MANUFACTURING SITE TRANSFER FROM BARCELONETA TO ASCOLI FOR PRAZOSIN HYDROCHLORIDE CAPSULES IN HEALTHY ADULT PARTICIPANTS UNDER FASTED CONDITIONS
ClinicalTrials.gov ID: NCT04967443
Acronym / sponsor ID: A0281006
Conditions: Hypertension, Heart Failure
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 22 Sep 2021 (actual)
Primary completion: 15 Feb 2022 (actual)
Study completion: 15 Feb 2022 (actual)
First posted: 19 Jul 2021 (actual)
Results: Posted 12 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Prazosin Hydrochloride (HCL) 2 milligram (mg) capsule Barceloneta site	Active comparator	Drug: Prazosin HCl 2mgOne 2 mg capsule manufactured at the current site, Barceloneta
Prazosin HCL 2 mg capsule Ascoli site	Experimental	Drug: Prazosin HCl 2mgOne 2 mg capsule manufactured at the proposed site (Ascoli)
Prazosin HCL 1 mg capsule Ascoli site	Experimental	Drug: Prazosin HCl 1 mgTwo 1 mg capsule manufactured at the proposed site, Ascoli
Prazosin HCL 5 mg capsule Barceloneta site	Active comparator	Drug: Prazosin HCl 5 mgOne 5 mg capsule manufactured at the current site, Barceloneta
Prazosin HCL 1 x 5 mg capsule Ascoli site	Active comparator	Drug: Prazosin HCl 5 mgOne 5 mg capsule manufactured at the proposed site, Ascoli

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Participants must be 18 to 55 years of age, inclusive, at the time of signing the Informed Consent Document (ICD).
Male and female participants who are overtly healthy as determined by medical evaluation including medical history, full physical examination, vital signs, 12-lead electrocardiogram (ECG), and/or clinical laboratory tests.
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations , and other study procedures.
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Key exclusion criteria (13 listed)

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
Any condition possibly affecting drug absorption (eg, gastrectomy).
History of Human Immunodeficiency Virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb) or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.
A positive urine drug test.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Prazosin HCl 2mgAlso: Minipress 2 mg capsule.Prazosin HCL 1 X 2 mg capsule.	Drug	Prazosin HCL 2 mg capsule Ascoli site, Prazosin Hydrochloride (HCL) 2 milligram (mg) capsule Barceloneta site
Prazosin HCl 1 mgAlso: Minipress 1 mg capsule.Prazosin HCl 2 X 1 mg capsule.	Drug	Prazosin HCL 1 mg capsule Ascoli site
Prazosin HCl 5 mgAlso: Minipress 5 mg capsule.Prazosin HCL 1 X 5 mg capsule.	Drug	Prazosin HCL 1 x 5 mg capsule Ascoli site, Prazosin HCL 5 mg capsule Barceloneta site

Primary outcome

Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Prazosin
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of each period
Maximum Observed Plasma Concentration (Cmax) of Prazosin
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of each period

4 secondary outcomes

Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Prazosin
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of each period
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Prazosin
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of each period
Plasma Decay Half-Life (t1/2) of Prazosin
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of each period
Number of Participants With Adverse Events (AEs) According to Seriousness
Time frame: Time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.

Results and safety

Results posted to the registry on 12 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Prazosin HCL 1x2 mg (Barceloneta) => Prazosin HCL 1x2 mg (Ascoli) => Prazosin HCL 2x1 mg (Ascoli)	6	6
Prazosin HCL 1x2 mg (Barceloneta) => Prazosin HCL 2x1 mg (Ascoli) => Prazosin HCL 1x2 mg (Ascoli)	6	6
Prazosin HCL 1x2 mg (Ascoli) => Prazosin HCL 1x2 mg (Barceloneta) => Prazosin HCL 2x1 mg (Ascoli)	6	6
Prazosin HCL 1x2 mg (Ascoli) => Prazosin HCL 2x1 mg (Ascoli) => Prazosin HCL 1x2 mg (Barceloneta)	6	6
Prazosin HCL 2x1 mg (Ascoli) => Prazosin HCL 1x2 mg (Barceloneta) => Prazosin HCL 1x2 mg (Ascoli)	6	6
Prazosin HCL 2x1 mg (Ascoli) => Prazosin HCL 1x2 mg (Ascoli) => Prazosin HCL 1x2 mg (Barceloneta)	6	6
Prazosin HCL 1x5 mg (Barceloneta) => Prazosin HCL 1x5 mg (Ascoli)	18	18
Prazosin HCL 1x5 mg (Ascoli) => Prazosin HCL 1x5 mg (Barceloneta)	18	18

Primary outcome: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Prazosin

Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of each period. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram*hour per milliliter (ng*hr/mL)

Measure	Prazosin HCL 1x2 mg (Barceloneta) n = 34	Prazosin HCL 1x2 mg (Ascoli) n = 33	Prazosin HCL 2x1 mg (Ascoli) n = 32	Prazosin HCL 1x5 mg (Barceloneta) n = 33	Prazosin HCL 1x5 mg (Ascoli) n = 34
Value	85.77 (34)	88.37 (31)	92.39 (34)	192.3 (147)	252.2 (37)

Prazosin HCL 1x2 mg (Ascoli): Ratio of adjusted geometric means: 102.10 (90% CI 96.14 to 108.43), Mixed Models Analysis
Prazosin HCL 2x1 mg (Ascoli): Ratio of adjusted geometric means: 104.87 (90% CI 98.68 to 111.44), Mixed Models Analysis
Prazosin HCL 1x5 mg (Barceloneta) vs Prazosin HCL 1x5 mg (Ascoli): Ratio of adjusted geometric means: 104.45 (90% CI 99.58 to 109.55), Mixed Models Analysis

Population analysed: The AUClast analysis population is defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of Prazosin

Measure	Prazosin HCL 1x2 mg (Barceloneta) n = 34	Prazosin HCL 1x2 mg (Ascoli) n = 33	Prazosin HCL 2x1 mg (Ascoli) n = 33	Prazosin HCL 1x5 mg (Barceloneta) n = 33	Prazosin HCL 1x5 mg (Ascoli) n = 34
Value	14.82 (49)	17.04 (36)	19.20 (37)	30.91 (143)	38.69 (132)

Prazosin HCL 1x2 mg (Ascoli): Ratio of adjusted geometric means: 113.96 (90% CI 102.79 to 126.34), Mixed Models Analysis
Prazosin HCL 2x1 mg (Ascoli): Ratio of adjusted geometric means: 126.83 (90% CI 114.32 to 140.70), Mixed Models Analysis
Prazosin HCL 1x5 mg (Barceloneta) vs Prazosin HCL 1x5 mg (Ascoli): Ratio of adjusted geometric means: 118.07 (90% CI 106.46 to 130.94), Mixed Models Analysis

Population analysed: The Cmax analysis population is defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. Actual time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Prazosin HCL 1x2 mg (Barceloneta)	1 of 34 (2.9%)	8 of 34 (23.5%)	1 of 34
Prazosin HCL 1x2 mg (Ascoli)	0 of 33 (0%)	4 of 33 (12.1%)	0 of 33
Prazosin HCL 2x1 mg (Ascoli)	0 of 33 (0%)	5 of 33 (15.2%)	0 of 33
Prazosin HCL 1x5 mg (Barceloneta)	0 of 33 (0%)	16 of 33 (48.5%)	0 of 33
Prazosin HCL 1x5 mg (Ascoli)	0 of 34 (0%)	18 of 34 (52.9%)	0 of 34

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Prazosin HCl 2mg, Prazosin HCl 1 mg and Prazosin HCl 5 mg in people with Hypertension and Heart Failure, run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Prazosin (time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of each period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04967443.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.