Study of Atenolol Influence on Blood Pressure During Resi... | NCT01030016

Studies
Study of Atenolol Influence on Blood Pressure During Resistance Exercise

NCT01030016

Sponsor

University of Sao Paulo

Status

Completed

Last Update Posted

Dec 15, 2009Estimated

Enrollment

10Actual

Phase

Phase 4

Conditions

Blood Pressure
Exercise

Interventions

atenolol

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

May 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Dec 8, 2009

First Submission Date that Met QC Criteria

Dec 9, 2009

First Posted Date

Dec 10, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2009

Last Update Posted Date

Dec 15, 2009Estimated

Name	Class
Fundação de Amparo à Pesquisa do Estado de São Paulo	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
atenolol	Experimental	subjects received 6 weeks of atenolol	Drug: atenolol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
atenolol	Drug	25 mg/day, twice a day for 6 weeks	atenolol	beta-blockers

Measure	Description	Time Frame
blood pressure during resistance exercise		6 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

hypertension with blood pressure levels below 160/105 mmHg under placebo.
age between 30 and 60 years
nonobese

Exclusion Criteria:

target organ lesion
cardiovascular risk factor
cardiovascular disease
physically active

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cláudia LM Forjaz, PhD	University of Sao Paulo	Principal Investigator
Decio Mion Jr, PhD	University of Sao Paulo	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of São Paulo		São Paulo	São Paulo	05508030	Brazil

ID	Term
D009043	Motor Activity

ID	Term
D001519	Behavior

Intervention Browse Module

MeSH Terms

ID	Term
D001262	Atenolol
D000319	Adrenergic beta-Antagonists

Ancestor Terms

ID	Term
D050198	Phenoxypropanolamines
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols

Browse Leaves

Not provided

Browse Branches

Not provided