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

Phase 3

Not yet recruiting

• Conditions: Essential (primary) hypertension,

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

Brief Summary

A Prospective, Randomized, Double-blind, Double-dummy, Parallel-group Investigator-initiated Study to Compare the Efficacy and Safety of Cilnidipine 10 mg Tablets versus Cilacar® Tablets 10 mg in Patients with Essential Hypertension,sample size 30,for 30 days Primary Efficacy Objective To evaluate the efficacy of investigational products in patients with essential hypertension on Day 30 (±4 days) of treatment as assessed by change from baseline in sitting SBP and DBP

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-15
• Last Update Posted: 2021-10-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

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

Primary Outcome Measures

Name	Time	Method
Change from baseline in sitting SBP and DBP on Day 30 (±4 days) in both treatment groups	30 Days

Secondary Outcome Measures

Name	Time	Method
Change from baseline in sitting SBP and DBP on Day 15 (±4 days) in both treatment groups Proportion of patients achieving goal BP during the study in both treatment groups at the end of treatment from baseline (Day 30 [± 4 days]) Change from baseline in body weight, pulse rate, pedal edema and ankle circumference (right and left) on Day 15(±4 days) and Day 30(±4 days) in both treatment groups. Change in spot urine-protein creatinine ratio on Day 30 (±4 days) from baseline	30 Days

Trial Locations

Locations (1)

Plantina Heart Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Plantina Heart Hospital

🇮🇳Nagpur, MAHARASHTRA, India

Dr Pramod Mundra

Principal investigator

9823026651

pramod_mundra@rediffmail.com