CTRI/2022/04/042233
Not yet recruiting
未知
A Prospective, Randomized, Double-blind, Double-dummy,Parallel-group,Investigator-initiated Study to Evaluate the Efficacy and Safety of Cilnidipine 10mg Tablet versus Amlodipine 10 mg Tablet in Patients with Newly DiagnosedHypertension
Dr Amey Beedkar0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Dr Amey Beedkar
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adult male or female patients between 18 to 65 years (both agesinclusive).
- •2\. Patients with newly diagnosed hypertension with blood pressuremore than or equal to 140/90 mmHg.
- •3\. Serum creatinine within the normal range defined by the locallaboratory.
- •4\. Patients willing to give their written informed consent to participatein the study.
- •5\. Patients willing to comply with all aspects of the protocol.
Exclusion Criteria
- •1\. Blood pressure more than or equal to 180/110 mmHg.
- •2\. Patients hypersensitive to active or inactive ingredients of investigational products.
- •3\. Patients with uncontrolled diabetes mellitus at screening (uncontrolled defined as patients withHbA1c more than or equal to 8% with or without treatment).
- •4\. Patients with recurrent symptomatic hypotension.
- •5\. Patients with uncontrolled kidney disease requiring dialysis or renal replacement therapy.
- •6\. Apparent/pseudo hypertension due to white coat effect, and medical inertia.
- •7\. Patients with known history of heart failure, and reduce cardiac function.
- •8\. Patients with concomitant causes of edema including, nephropathy, cardiac failure, hepatic cirrhosis, use of antidiabetic medications known to cause edema andhypoalbuminemia due to any other cause, will be excluded by renal and liver function tests, thyroid profile, and baseline echocardiography.
- •9\. Patients with varicose veins.
- •10\. Patients with nephrotic syndrome, hypoproteinemia, or microalbuminuria
Outcomes
Primary Outcomes
Not specified
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