Blood PressurePhase 4NCT01030016
Study of Atenolol Influence on Blood Pressure During Resistance Exercise
A Phase 4 study testing atenolol in people with Blood Pressure and Exercise, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The study was designed to investigate if atenolol is able to blunt blood pressure increase during resistance exercise in hypertensive subjects. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Blood Pressure, Exercise
- What is being tested?
- atenolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- May 2007to May 2009
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- hypertension with blood pressure levels below 160/105 mmHg under placebo.
- age between 30 and 60 years
- nonobese
Who cannot join
- target organ lesion
- cardiovascular risk factor
- cardiovascular disease
- physically active
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blood Pressure Response During Resistance Exercise in Hypertensives: Influence of Beta-blockers
The study was designed to investigate if atenolol is able to blunt blood pressure increase during resistance exercise in hypertensive subjects.
Read the detailed description
The study compared intra-arterial blood pressure responses during leg-extension resistance exercise performed to fatigue at 40, 80 and 100% of 1 RM in hypertensive patients receiving placebo (first) and atenolol (second) on a single blind manner.
- Conditions
- Blood Pressure, Exercise
- Being tested
- atenolol
- Keywords
- resistance exercise, beta-blockers, blood pressure
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atenololDrug
Also called beta-blockers
25 mg/day, twice a day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| atenolol | Experimental | subjects received 6 weeks of atenolol Receives: Drug: atenolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure during resistance exercise
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2009 (estimated)
- Study startMay 2007
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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 4
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Investigators
- Cláudia LM Forjaz, PhD, Principal investigator, University of Sao PauloDecio Mion Jr, PhD, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030016
- Sponsor's protocol ID
- FAPESP-06/06356-8
- Status last verified
- May 2009
- First submitted
- 8 Dec 2009
- Last updated
- 15 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure Response During Resistance Exercise in Hypertensives: Influence of Beta-blockers
- ClinicalTrials.gov ID
- NCT01030016
- Acronym / sponsor ID
- FAPESP-06/06356-8
- Conditions
- Blood Pressure, Exercise
- Keywords
- resistance exercise, beta-blockers, blood pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- May 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 10 Dec 2009 (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 study was designed to investigate if atenolol is able to blunt blood pressure increase during resistance exercise in hypertensive subjects.
Detailed description
The study compared intra-arterial blood pressure responses during leg-extension resistance exercise performed to fatigue at 40, 80 and 100% of 1 RM in hypertensive patients receiving placebo (first) and atenolol (second) on a single blind manner.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| atenolol | Experimental | Drug: atenololsubjects received 6 weeks of atenolol |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- hypertension with blood pressure levels below 160/105 mmHg under placebo.
- age between 30 and 60 years
- nonobese
Key exclusion criteria (4 listed)
- target organ lesion
- cardiovascular risk factor
- cardiovascular disease
- physically active
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 |
|---|---|---|
| atenololAlso: beta-blockers25 mg/day, twice a day for 6 weeks | Drug | atenolol |
Primary outcome
blood pressure during resistance exercise
Time frame: 6 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 15 Dec 2009.
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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.
Cláudia LM Forjaz, PhD principal investigator
University of Sao Paulo
Decio Mion Jr, PhD study chair
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing atenolol in people with Blood Pressure and Exercise, run by University of Sao Paulo at 1 site in Brazil.
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 4 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 15 Dec 2009. 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 Brazil. 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?
blood pressure during resistance exercise (time frame: 6 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 15 Dec 2009.