Home » Trials » SLCTR/2013/006
A randomized, double blind, controlled clinical trial of S-Amlodipine versus conventional Amlodipine, to compare the incidence of leg edema and antihypertensive efficacy in patients with hypertension
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SLCTR Registration Number
SLCTR/2013/006
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
A randomized, double blind, controlled clinical trial of S-Amlodipine versus conventional Amlodipine, to compare the incidence of leg edema and antihypertensive efficacy in patients with hypertension
Public Title of Trial
A randomized, double blind, controlled clinical trial of S-Amlodipine versus conventional Amlodipine, to compare the incidence of leg edema and antihypertensive efficacy in patients with hypertension
Disease or Health Condition(s) Studied
Hypertension, leg oedema
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
S-Amlo/HTN/SL/2010
What is the research question being addressed?
What is the antihypertensive efficacy and the incidence of leg oedema with S-amlodipone compared to conventional amlodipine in patients with uncontrolled essential hypertension while on single or combination therapy?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Active
Assignment
Parallel
Purpose
Other
Study Phase
Not Available
Intervention(s) planned
The test medication (S-amlodipine: ASOMEX tablets 2.5 mg / 5 mg [Emcure Pharmaceuticals, India]) and the reference medication (Conventional amlodipine: Amlogard tablets 5 mg /10 mg [ Pfizer –India]) will be dispensed in sachets. The study will have two arms. Subjects in the test arm will receive sachets containing 5mg of S-amlodipine (2 tablets) while the subjects in the control arm will receive sachets containing 10mg of conventional amlodipine (2 tablets). Subjects will be instructed to consume the contents of the sachets once daily (morning/evening) for 120 days. The investigator may decrease the dose of the medication in case of achievement of adequate BP control as follows: Test medication: Starting Dose 5 mg. Modify to 2.5 mg (if BP < 115/75 mm Hg OR adverse event). Reference Medication: Starting Dose 10 mg. Modify to 5 mg (if BP < 115/75 mm Hg OR adverse event).
Inclusion criteria
30-64 years of age • Diagnosed essential hypertension with either systolic BP > 140mmHg or diastolic BP > 90 mmHg or both while in the seated position • On beta blockers and ACE inhibitor /Angiotensin receptor blocker for at least 4 weeks • Consenting and willing to comply with study protocol
Exclusion criteria
Known hypersensitivity to amlodipine, calcium channel blockers or to any ingredients of the test/reference medication • Patients on calcium channel blockers or antihypertensive therapy other than ACE inhibitors or Angiotensin receptor blockers • Secondary hypertention • Clinical diagnosis of resistant or malignant hypertension • History of myocardial infarction or congestive cardiac failure • PTCA, CABG, cerebrovascular accident, or TIA in last 6 months • Diagnosed cardiac arrhythmias and/or any other abnormality on ECG • Significant respiratory /liver/ kidney/neurological diseases/ coagulation disorders • Metabolic or endocrine disorders (except Type 2 diabetes mellitus • Type 2 diabetes mellitus taking insulin or oral hypoglycemic drugs other than metformin or sulfonylurea or patients on more than one sulfonylurea • Pregnant and lactating women or women in the reproductive age group not practicing effective means of contraception. • Known alcohol or drug abuse Any condition that, in the opinion of the investigator, does not justify the patient’s inclusion in the study.
Primary outcome(s)
|
1.
Proportion of patients having peripheral edema (pitting oedema), not attributable to any concomitant drug, as assessed clinically at the following anatomical points: proximal to medial malleolus, behind medial malleolus and dorsum of the foot. |
[ At baseline and at 16 weeks (end of therapy) ] |
Secondary outcome(s)
|
1.
Responder rate: Subjects showing reduction in systolic blood pressure by >/= 20 mm of Hg and / or diastolic blood pressure by >/= 10 mm or those achieving systolic blood pressure </=140 mm of Hg and diastolic blood pressure </= 90 mm of Hg 2. The following will be assessed monthly a. Systolic, diastolic and mean blood pressure (B.P.) b. Change in pitting oedema scores (combined scores for all 3 points) c. Change in ankle circumference d. Difference in patient assessment questionnaire 3. Subject’s global assessment about the tolerability of the drug 4. Physician’s global assessment about the tolerability of the drug 5. Percentage of the subjects experiencing any drug related adverse event not attributed to any concomitant drug, as evaluated and recorded by the investigator 6. Change in investigational parameters: CBC (Complete Blood Count), LFT (Liver Function test), Lipid profile, FBG (Fasting Blood Glucose), Urine examination and ECG (Electrocardiogram) |
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Target number/sample size
146 (73 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2013-02-15
Anticipated end date
2013-08-01
Date of first enrollment
2013-08-30
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
Emcure pharmaceuticals Limited, India.
Regulatory approvals
Status
Approved
Date of Approval
2012-08-27
Approval number
EC-10-014
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
DR. R.A.I. Ekanayake
Consultant Cardiologist
Institute of Cardiology, National Hospital of Sri Lanka, Colombo, Sri Lanka.
+94 112691111 Ext:643 +94 112692823
ruvan_nishali.ekanayaka@yahoo.com
Contact Person for Public Queries
Dr Priyadarshani Galappatthy
Consultant Physician, Senior Lecturer and Head, Department of Pharmacology, Faculty of Medicine University of Colombo.
Faculty of Medicine University of Colombo PO Box 271 Kynsey Road Colombo 8 Sri Lanka.
0094 112697483 0094 112697483
priyadarshani1232000@yahoo.com
Primary study sponsor/organization
Emcure Pharmaceuticals Limited
Hinjwadi, Pune – 411057, India
+91-20-39821081 +91-20-39821019
medical@emcure.co.in
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
