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CTRI Number  CTRI/2018/06/014662 [Registered on: 28/06/2018] Trial Registered Retrospectively
Last Modified On: 08/06/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   pattern of use of antihypertensive agents in elderly hypertensive patients with or without concomitant diseases. 
Scientific Title of Study   A study of the pattern of antihypertensive use in elderly subjects with or without comorbid conditions 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Champakala C 
Designation  PG  
Affiliation  KIMS, Bangalore 
Address  Department of Pharmacology, KIMS, Bangalore

Bangalore
KARNATAKA
560070
India 
Phone  9008061029  
Fax    
Email  champachannappa@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jyothi R 
Designation  Associate Professor 
Affiliation  KIMS, Bangalore 
Address  Department of Pharmacology, KIMS, Bangalore

Bangalore
KARNATAKA
560070
India 
Phone  9845612562  
Fax    
Email  sanjyothi03@gmail.com  
 
Details of Contact Person
Public Query  
Name  DRChampakala C 
Designation  PG  
Affiliation  KIMS, Bangalore 
Address  Department of Pharmacology, KIMS, Bangalore

Bangalore
KARNATAKA
560070
India 
Phone  9008061029  
Fax    
Email  champachannappa@gmail.com  
 
Source of Monetary or Material Support  
KIMSH,K.R.Road,Bangalore,karnataka 
 
Primary Sponsor  
Name  DR Champakala C 
Address  PG,Department of Pharmacology, KIMS,Bangalore 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR Champakala C  KIMS Hospital  Department of Medicine, KIMS Hospital,KR Road, Bangalore
Bangalore
KARNATAKA 		 9008061029

champachannappa@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KIMS IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Elderly hypertensive patients aged more than 60 years with or without co morbid conditions,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Elderly patients of either gender aged 60 years and above with hypertension, with or without co morbid conditions, receiving anti hypertensive medications for more than 6 months 
 
ExclusionCriteria 
Details  Subjects with acute complications such as MI,Left Ventricular Failure,Cerebrovascular events, hypertensive emergencies or acute renal failure.
Subjects hospitalized for any other conditions.
Subjects with terminal illness due to malignancy.
Subjects with severe psychiatric illness or cognitive impairment.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the pattern of anti hypertensive prescribing for elderly with or without coorbidities   18 months 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the medication compliance and quality of life in the study subjects  18 months 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
Final Enrollment numbers achieved (Total)= "250"
Final Enrollment numbers achieved (India)="250" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2016 
Date of Study Completion (India) 30/06/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
   

1)            1) Prescriptions of 250 elderly hypertensive subjects with or without co morbidity were assessed for the pattern of anti hypertensive agents use.

2)     The mean age of the study subjects was 67.9 ± 4.05 years and out of 250 subjects, 119 subjects received anti hypertensive agents as mono therapy, includes anti hypertensive agents such as CCB (47.8%), ARB (34.5%), beta blockers (13.4%), ACEI (3.4%) & alpha blockers (0.8%).

3)     The two most commonly prescribed anti hypertensive agents in the study either as mono therapy or in combination with the other anti hypertensive agents were ARB (55%) & CCB (55%).

4)     Dual anti hypertensive combination therapy was prescribed to 100 subjects and the most common dual anti hypertensive combination therapy was ARB + thiazide diuretic. Triple anti hypertensive agents combination therapy was prescribed to 26 subjects, 3 subjects received 4-anti hypertensive agents combination therapy and only 1 subject was prescribed with 5-anti hypertensive agents combination therapy.

5)     42.8% of the study population received antihypertensive FDCs. There were 20 different FDCs of antihypertensive agents prescribed in the study, Telmisartan + hydrochlorthiazide was the most commonly prescribed FDC.

6)     The level of medication compliance was assessed by 8-item questionnaire as per MMAS-8. Compliance level was good in 41.2% subjects, moderate in 48.4% subjects & poor in 10.4% subjects. Compliance level in the present study was influenced by various factors such as age, gender, socioeconomic status, comorbidities, severity of hypertension, number of medications, and cost of medications.

7)     HRQoL in the study subjects was assessed by 17-item questionnaire as per MINICHAL Scale. In our study it has shown that HRQoL in the subjects was influenced by severity of hypertension in the study.

 
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