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Effects of Doxazosin Gastrointestinal Therapeutic System on Ambulatory Blood Pressure and Cardiovascular Risk Factors in Uncontrolled Hypertensive Patients

Last updated on December 4, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Brescia, , 25123 Italy
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Eligible subjects were males or females ≥18 years of age with a diagnosis of primary
essential hypertension and currently taking 1 or 2 individual antihypertensive agents

- Dosing for entry antihypertensive medication was at the accepted efficacious dose or
the maximum tolerated dose and had to be stable for at least 4 weeks prior to study
entry

- Subjects were required to have clinic sitting DBP ≥95 and ≤110 mmHg and SBP ≥140 and
≤180 mmHg as an average of 3 readings on their current antihypertensive therapy at
visits 1 and 2

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

Exclusion criteria included, but were not limited to:

- Subjects taking antihypertensive medications for other indications (i.e. arrhythrma,
unstable angina, CHF, etc.)

- Orthostatic hypotension, defined as a decrease of at least 20 mmHg systolic or 1OmmHg
diastolic pressure between sitting and standing blood pressures after 2 rmnutes, or
known fluid depletion.

NCT00646841
Pfizer
Completed
Effects of Doxazosin Gastrointestinal Therapeutic System on Ambulatory Blood Pressure and Cardiovascular Risk Factors in Uncontrolled Hypertensive Patients

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Descriptive Information
Brief Title  ICMJE Effects of Doxazosin Gastrointestinal Therapeutic System on Ambulatory Blood Pressure and Cardiovascular Risk Factors in Uncontrolled Hypertensive Patients
Official Title  ICMJE The Effects of Doxazosin Gastrointestinal Therapeutic System (GITS) on Ambulatory Blood Pressure and Cardiovascular Risk Factors in Uncontrolled Hypertensives on Drug Therapy
Brief SummaryThe primary objective was to determine the effects of the Gastrointestinal Therapeutic System (GITS) formulation of Doxazosin when used in combination therapy with the 5 major classes of antihypertensive agents as measure by 24-hour diastolic blood pressure.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE Drug: Doxazosin gastrointestinal therapeutic system (GITS)
4 mg/day, and was titrated, if necessary, to 8 mg/day at Week 3 (Visit 5) or Week 5 (Visit 6).
Study Arms  ICMJE Experimental: A
Intervention: Drug: Doxazosin gastrointestinal therapeutic system (GITS)
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 26, 2008)
89
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2004
Actual Primary Completion DateFebruary 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Eligible subjects were males or females ?18 years of age with a diagnosis of primary essential hypertension and currently taking 1 or 2 individual antihypertensive agents
  • Dosing for entry antihypertensive medication was at the accepted efficacious dose or the maximum tolerated dose and had to be stable for at least 4 weeks prior to study entry
  • Subjects were required to have clinic sitting DBP ?95 and ?110 mmHg and SBP ?140 and ?180 mmHg as an average of 3 readings on their current antihypertensive therapy at visits 1 and 2

Exclusion Criteria:

Exclusion criteria included, but were not limited to:

  • Subjects taking antihypertensive medications for other indications (i.e. arrhythrma, unstable angina, CHF, etc.)
  • Orthostatic hypotension, defined as a decrease of at least 20 mmHg systolic or 1OmmHg diastolic pressure between sitting and standing blood pressures after 2 rmnutes, or known fluid depletion.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00646841
Other Study ID Numbers  ICMJE A0351051
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateAugust 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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