CTRI/2024/05/068049 [Registered on: 29/05/2024] Trial Registered Prospectively
Last Modified On:
28/05/2024
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group Trial
Public Title of Study
A clinical trial to study the effects and safety of two drugs, amlodipine and s-amlodipine in patients with mild to moderate blood pressure for 16 weeks
Scientific Title of Study
Comparison of efficacy , safety and cost effectiveness of Amlodipine versus
S-Amlodipine in patients with Grade I and grade II hypertension- a
prospective, Randomised controlled trial , 16-weeks Double Blind study.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
nil
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dhwani Patel
Designation
Junior Resident
Affiliation
Indira Gandhi Government Medical College and Hospital, Nagpur
Address
Dr.Dhwani Patel , Junior Resident ,Department. of Pharmacology, Indira
Gandhi Government Medical College and Hospital, CA road, Nagpur,
Maharashtra
Nagpur
MAHARASHTRA
440018
India
Nagpur MAHARASHTRA 440018 India
Phone
8983763613
Fax
Email
dhwaniptl11@gmail.com
Details of Contact Person Scientific Query
Name
Sachin Hiware
Designation
Associate Professor
Affiliation
Indira Gandhi Government Medical College and Hospital, Nagpur,
Address
Dr. Sachin Hiware, Associate Professor ,Department. of Pharmacology, Indira
Gandhi Government Medical College and Hospital, CA road, Nagpur,
Maharashtra
Nagpur
MAHARASHTRA
440018
India
Nagpur MAHARASHTRA 440018 India
Phone
9823426746
Fax
Email
dr.hiware@gmail.com
Details of Contact Person Public Query
Name
Dhwani Patel
Designation
Junior Resident
Affiliation
Indira Gandhi Government Medical College and Hospital, Nagpur
Address
Dr.Dhwani Patel , Junior Resident ,Department. of Pharmacology, Indira
Gandhi Government Medical College and Hospital, CA road, Nagpur,
Maharashtra
Nagpur
MAHARASHTRA
440018
Nagpur MAHARASHTRA 440018 India
Phone
8983763613
Fax
Email
dhwaniptl11@gmail.com
Source of Monetary or Material Support
Indira Gandhi Government Medical College and Hospital, Nagpur.
Primary Sponsor
Name
Indira Gandhi Government Medical College and Hospital, Nagpur.
Address
Indira
Gandhi Government Medical College and Hospital, CA road, Nagpur,
Maharashtra
Nagpur
MAHARASHTRA
440018
India
Type of Sponsor
Research institution and hospital
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
DrDhwani Patel
Indira Gandhi Government Medical College and Hospital, Nagpur
Department of Pharmacology ,Indira
Gandhi Government Medical College and Hospital, CA road, Nagpur,
Maharashtra
Nagpur
MAHARASHTRA
440018
India Nagpur MAHARASHTRA
8983763613
dhwaniptl11@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Institutional Ethics Committee(IEC)/ Board Of Research Studies (BORS) Indira Gandhi Government medical college and Hospital
2.5 mg Tablet Given Orally once a day for 16 weeks.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
75.00 Year(s)
Gender
Both
Details
1. Male and female patients aged 18 to 75 years
2. Diagnosed with grade I & II hypertension ( Systolic BP between 140-179 mmHg and/or Diastolic BP between 90-109 mmHg).
3. Patients who are able to comply with the study protocol ,attend scheduled visits ,willingness to participate in the study and provide informed consent.
4. OutPatient Department
ExclusionCriteria
Details
1.Previous History of myocardial infarction , PTCA , CABG, angina pectoris or cerebrovascular accidents in the last 6 months .
2.History of secondary or malignant hypertension
3.History of congestive cardiac failure , cardiac arrhythmias, any other abnormalities in ECG.
4.Patient with known significant respiratory conditions .
5. Patient with known significant Neurological diseases , Coagulation disorders , metabolic or endocrine disorder (except Type 2 Diabetes Mellitus)
6. Uncontrolled Diabetes Mellitus (fasting blood glucose more than 140 mg/dl ) or diabetic edema or Type 2 Diabetes Mellitus taking insulin or oral hypoglycemic drugs other than Metformin or sulfonylureas and more than one sulfonylureas.
7. Patient with Liver or Kidney disorder
8. Patients who may develop edema feet by concomitant drug at screening :
a. Drugs that constrict intra renal blood vessels (eg. NSAIDS , Cyclosporine etc.)
b. Drugs that dilate arterioles (eg .vasodilators etc)
c. Drugs that increase sodium reabsorption in the kidneys (eg steroids)
d.Drugs that damage capillaries (eg interleukins 2 )
e. Glitazone based drugs for diabetes
9.Known Hypersensitivity to CCBs.
10. Patients with psychiatric disorder .
11.Those who are taking the drugs that may cause drug interactions.
a.Drugs that may change the plasma concentration of amlodipine (eg.CYP3A4 inducers -Rifampicin , St.johns wort)
b.Drugs that may increase the antihypertensive action {(eg. other antihypertensives -CCBs , Beta blockers , ACEi , ARBs, Alpha blockers , diuretics , Ntg ),(TCAs- Amitriptyline , desipramine, imipramine, nortriptyline, protriptyline, trimipramine ),nitrate formulations ,baclofen , pioglitazone , sildenafil etc.}
c. Systemic corticosteroids ( fluocinolone , triamcinolone) etc . : Local steroid application allowed.
d.Drugs that may increase the inhibitory action of muscle contraction .( eg-antiarrhythmics -amiodarone, quinidine) etc.
e.Drugs that may cause ventricular spasms (eg. intravenous administration of dantrolene and verapamil)
f.Drugs that may increase the risk of hypotension (eg CYP3A4 inhibitors -clarithromycin ) etc.
12.Patients with a history of malignancy within the last 5 years.
13. Pregnant and lactating women or the women in the reproductive age group not practicing the effevtive means of contraception
14.Patients with known alcohol or drug abuse and any condition .
15.Patients in inpatient department.
16. Known case of immunodeficiency
17.Age less than 18 years and greater than 75 years
18.Participation in another clinical trial.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pre-numbered or coded identical Containers
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Mean Change in the blood pressure at the end of 16 weeks
Mean Change in the blood pressure will be estimated at baseline and 16 weeks
Secondary Outcome
Outcome
TimePoints
Recording of adverse event, if any, according to
the prescribed proforma issued by
Pharmacovigilance program of India (PvPI).
adverse drug reactions are noted at any point of
time after drug intake
Analyzing the cost-effective analysis of antihypertensive drug mentioned in the trial
cost effective analysis will be done at baseline & 16 weeks.
Target Sample Size
Total Sample Size="94" Sample Size from India="94" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 4
Date of First Enrollment (India)
15/06/2024
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="4" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This study is a prospective, Randomised controlled trial , 16-weeks Double Blind study to Compare the efficacy , safety and cost effectiveness of Amlodipine versus S-Amlodipine in patients with Grade I and grade II hypertension .Subjects will be recruited in the Medicine outpatient Department of a tertiary care teaching hospital. Although several clinical trials comparing amlodipine and (S)-amlodipine have been done, the literature lacks with properly conducted trial comparing the efficacy, safety and cost effect between the two drugs in patients in Indian scenario.Hence this clinical trial is planned in central India with aim to fill the existing knowledge gap regarding the safety, efficacy, and cost-effectiveness of amlodipine and S-amlodipine in Indian Scenario. The study is approved by the Institutional Ethics committee and will be done according to the ICMR guidelines for Biomedical Research on Human subjects.04:06 PM