Protocol summary

Summary
Hypertension is one of the most important and common health problems in societies. Hypertension is often asymptomatic and can be simply treated if HTN is not treated, it can result in serious morbidity and mortality. Varieties of drugs are available for treatment of HTN Including: Diuretics, beta bulkers, blockers of calcium channel, angiotensin-converting enzyme inhibitors, angiotensin receptor antagonists, alpha bulkers and arterial dilators. This research was performed to evaluate the efficacy of some of these drugs on the hypertension. This may help to choose an appropriate medication for the treatment of hypertension stage II. 150 patients with hypertension who were not under antihypertensive treatment and did not Contraindications for use Hydrochlorothiazide, Enalapril and Atenolol were randomly allocated into three groups. The first group received Atenolol 50 mg daily, The second group hydrochlorothiazide 50 mg daily and The third group Enalapril 5 mg two daily. After three weeks blood pressure of patients was measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012110511371N1
Registration date: 2013-01-31, 1391/11/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-01-31, 1391/11/12
Registrant information
Name
Bita Shahbazzadegan
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 1551 2007
Email address
b.shahbaz@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardabil University of Medical Sciences
Expected recruitment start date
2006-03-21, 1385/01/01
Expected recruitment end date
2007-03-21, 1386/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
study of the effects of Atenolol, Enalapril and Hydrochlorothiazid on the Hypertension stage II in patients with hypertension
Public title
comparative of the effects of Atenolol, Enalapril and Hydrochlorothiazid
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: All patients with hypertension stage II referred to Buali Hospital in Ardabil; without medications of hypertension; without renal disease (Cr> 1.5); without electrolyte imbalances; no contraindications for use atenolol (asthma, heart block, bradycardia, hypotension); no contraindications for use hydrochlorothiazide (hyperuricemia, initial Hypraldstrvnysm; no contraindications for use enalapril (allergy, renal failure); wishing to participate in the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ardabil University of Medical Sciences
Street address
Ardabil. University street
City
Ardabil
Postal code
Approval date
2006-09-23, 1385/07/01
Ethics committee reference number
0264

Health conditions studied

1

Description of health condition studied
Hypertension
ICD-10 code
I11.9
ICD-10 code description
Hypertensive heart disease without (congestive) heart failure

Primary outcomes

1

Description
hypertension
Timepoint
Before the experiment, three weeks after intervention
Method of measurement
Mm Hg, using a mercury manometer

Secondary outcomes

empty

Intervention groups

1

Description
The first group were given atenolol 50mg once daily (three weeks).
Category
Treatment - Drugs

2

Description
The second group enalapril 5mg every 12 hours (three weeks).
Category
Treatment - Drugs

3

Description
The third group Hydrochlorothiazide 50mg once daily (three weeks).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Heart Clinic of Booali Hospital
Full name of responsible person
Behzad Babapour
Street address
Ardabil University of Medical Sciences
City
Ardabil

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Behzad Babapour
Street address
Ardabil-University street
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Behzad Babapour
Position
Assistant professor of cardiology
Other areas of specialty/work
Street address
Ardabil University of Medical Sciences
City
Ardabil
Postal code
Phone
+98 45 1551 2007
Fax
Email
b.babapoursaatlou@arums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Behzad Babapour
Position
Assistant professor of cardiology
Other areas of specialty/work
Street address
Ardabil University of Medical Sciences
City
Ardabil
Postal code
Phone
+98 45 1551 2007
Fax
Email
b.babapoursaatlou@arums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Behzad Babapour
Position
Assistant professor of cardiology
Other areas of specialty/work
Street address
Ardabil University of Medical Sciences
City
Ardabil
Postal code
56197
Phone
+98 45 1551 2000
Fax
Email
b.babapoursaatlou@arums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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