Study to Compare the Efficacy and Safety of Cilnidipine 10 mg Tablets versus Cilacar® Tablets 10 mg in Patients with Essential Hypertensio

Phase 3

• Conditions: Health Condition 1: I10- Essential (primary) hypertension

• Registration Number: CTRI/2021/03/031882
• Lead Sponsor: MACLEODS PHARMACEUTICALS LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Patients with essential hypertension with blood pressure more than or equal to 140/90 mmHg

Patients who require monotherapy with Cilnidipine 10 mg tablets in the opinion of investigator

Serum creatinine within the normal range defined by the local laboratory

Patients willing to give their written informed consent to participate in the study

Patients willing to comply with all aspects of the protocol

Exclusion Criteria

Blood pressure more than or equal to 180/110 mmHg,hypersensitive to active or inactive ingredients of investigational products,uncontrolled diabetes mellitus at screening,symptomatic hypotension,uncontrolled kidney disease requiring dialysis or renal ,replacement therapy,Apparent/pseudo hypertension due to white coat effect, and medical inertia,known history of heart failure, and reduce cardiac function,pedal edema, nephrotic syndrome, hypoproteinemia or microalbuminuria,Female patients who are pregnant, lactating, or planning to become pregnant,patients not willing to use acceptable method of contraception,hematologic, hepatic, biliary obstructive disorders, neurologic psychiatric, renal, cardiovascularendocrine, or other diseases or receiving any medication that, in the opinion of the investigator, would put the patient at riskthrough study period, or would affect the study analyses,scheduled to undergo surgery during the study period,who have received any intervention in a clinical trial within 01 month prior to screening,history of alcohol and/or drug/substance abuse and current significant alcohol Consumption

Study & Design

• Study Type: Interventional
• Study Design: Not specified