HypertensionPhase 4NCT00646841
Effects of Doxazosin Gastrointestinal Therapeutic System on Ambulatory Blood Pressure and Cardiovascular Risk Factors in Uncontrolled Hypertensive Patients
A Phase 4 study testing Doxazosin gastrointestinal therapeutic system (GITS) in people with Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 7 sites in 4 countries.
Trial summary
The 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Doxazosin gastrointestinal therapeutic system (GITS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 7 sitesin 4 countries
- Study dates
- Feb 2003to Feb 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Italy3 sites
Pfizer Investigational Site
Brescia, 25123
Pfizer Investigational Site
Monza (Milan), 20052
Pfizer Investigational Site
Padova, 35128
Spain2 sites
Pfizer Investigational Site
Madrid, 28041
Pfizer Investigational Site
Palamós, Gerona, 17230
Location not given1 site
Pfizer Investigational Site
About this study
Official title: The Effects of Doxazosin Gastrointestinal Therapeutic System (GITS) on Ambulatory Blood Pressure and Cardiovascular Risk Factors in Uncontrolled Hypertensives on Drug Therapy
The 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.
- Conditions
- Hypertension
- Being tested
- Doxazosin gastrointestinal therapeutic system (GITS)
- Keywords
- Essential hypertension, doxazosin, ambulatory blood pressure monitoring
- Medical subject headings
- Hypertension, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxazosin gastrointestinal therapeutic system (GITS)Drug
4 mg/day, and was titrated, if necessary, to 8 mg/day at Week 3 (Visit 5) or Week 5 (Visit 6).
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Doxazosin gastrointestinal therapeutic system (GITS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effects of Doxazosin Gastrointestinal Therapeutic System (GITS) 4 or 8mg/day on mean 24-hour diastolic ambulatory blood pressure (ABP) when used in combination therapy in subjects with uncontrolled essential hypertension.
Measured: 11 weeks
Secondary outcomes (7)
Serum lipid levels (total cholesterol [TC], HDL cholesterol, calculated LDL cholesterol, triglycerides, calculated HDL/TC ratio)
Measured: 9 weeks
HgbA1C
Measured: 9 weeks
24-hour systolic ABP and 24-hour ambulatory heart rate
Measured: 9 weeks
daytime and nighttime (2200 to 0600 hours) ABP and ambulatory heart rate
Measured: 9 weeks
Sitting and standing clinic blood pressure (BP) and heart rate
Measured: 9 weeks
24-hour ABP smoothness index
Measured: 9 weeks
24-hour ABP and ambulatory heart rate between 24 hours (Week 9) and 48 hours (Week 9+1 day) after final dose of Doxazosin GITS
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2008 (estimated)
- Study startFeb 2003
- Primary completionFeb 2004
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646841
- Sponsor's protocol ID
- A0351051
- Status last verified
- Jan 2021
- First submitted
- 26 Mar 2008
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Doxazosin Gastrointestinal Therapeutic System (GITS) on Ambulatory Blood Pressure and Cardiovascular Risk Factors in Uncontrolled Hypertensives on Drug Therapy
- ClinicalTrials.gov ID
- NCT00646841
- Acronym / sponsor ID
- A0351051
- Conditions
- Hypertension
- Keywords
- Essential hypertension, doxazosin, ambulatory blood pressure monitoring
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Feb 2004 (actual)
- Study completion
- Feb 2004 (actual)
- First posted
- 31 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Doxazosin gastrointestinal therapeutic system (GITS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| 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). | Drug | A |
Primary outcome
To determine the effects of Doxazosin Gastrointestinal Therapeutic System (GITS) 4 or 8mg/day on mean 24-hour diastolic ambulatory blood pressure (ABP) when used in combination therapy in subjects with uncontrolled essential hypertension.
Time frame: 11 weeks
7 secondary outcomes
Serum lipid levels (total cholesterol [TC], HDL cholesterol, calculated LDL cholesterol, triglycerides, calculated HDL/TC ratio)
Time frame: 9 weeks
HgbA1C
Time frame: 9 weeks
24-hour systolic ABP and 24-hour ambulatory heart rate
Time frame: 9 weeks
daytime and nighttime (2200 to 0600 hours) ABP and ambulatory heart rate
Time frame: 9 weeks
Sitting and standing clinic blood pressure (BP) and heart rate
Time frame: 9 weeks
24-hour ABP smoothness index
Time frame: 9 weeks
24-hour ABP and ambulatory heart rate between 24 hours (Week 9) and 48 hours (Week 9+1 day) after final dose of Doxazosin GITS
Time frame: 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Doxazosin gastrointestinal therapeutic system (GITS) in people with Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 7 sites in 4 countries.
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 3 inclusion and 2 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 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy, Spain, United Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the effects of Doxazosin Gastrointestinal Therapeutic System (GITS) 4 or 8mg/day on mean 24-hour diastolic ambulatory blood pressure (ABP) when used in combination therapy in subjects with uncontrolled essential hypertension. (time frame: 11 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2021.