CTRI/2024/05/068049
Not yet recruiting
Phase 4
Comparison of efficacy , safety and cost effectiveness of Amlodipine versusS-Amlodipine in patients with Grade I and grade II hypertension- aprospective, Randomised controlled trial , 16-weeks Double Blind study. - NI
Indira Gandhi Government Medical College and Hospital, Nagpur.0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Indira Gandhi Government Medical College and Hospital, Nagpur.
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Not specified
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