| CTRI Number |
CTRI/2021/03/031882 [Registered on: 10/03/2021] Trial Registered Prospectively |
| Last Modified On: |
10/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study to Compare the Efficacy and Safety of Cilnidipine 10 mg Tablets versus Cilacar® Tablets 10 mg in Patients with Essential Hypertension |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT-022-CILN-2020 V 1.0/16-Jan-2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pramod Mundra |
| Designation |
Principal Investigator |
| Affiliation |
Platina Heart Hospital |
| Address |
Room No 3 , Department of Cardiology Platina Heart Hospital, Dhanashree Commercial Complex ,Dhantoli , Nagpur
Nagpur
MAHARASHTRA
440012
India |
| Phone |
9823026651 |
| Fax |
|
| Email |
pramod_mundra@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramod Mundra |
| Designation |
Principal Investigator |
| Affiliation |
Platina Heart Hospital |
| Address |
Room No 3, Department of Cardiology ,Platina Heart Hospital, Dhanashree Commercial Complex ,Dhantoli , Nagpur
Nagpur
MAHARASHTRA
440012
India |
| Phone |
9823026651 |
| Fax |
|
| Email |
pramod_mundra@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pramod Mundra |
| Designation |
Principal Investigator |
| Affiliation |
Platina Heart Hospital |
| Address |
Room 3 , Deaprtmet Of Cardiology Platina Heart Hospital, Dhanashree Commercial Complex ,Dhantoli , Nagpur
Nagpur
MAHARASHTRA
440012
India |
| Phone |
9823026651 |
| Fax |
|
| Email |
pramod_mundra@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| MACLEODS PHARMACEUTICALS LTD.
R & D III, Plot No. 18, Street No. 9, MIDC Area
Andheri-(East), Mumbai 400 093, India. |
|
|
Primary Sponsor
|
| Name |
MACLEODS PHARMACEUTICALS LTD |
| Address |
R & D III, Plot No. 18, Street No. 9, MIDC Area Andheri-(East), Mumbai 400 093, India. |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pramod Mundra |
Plantina Heart Hospital |
Room 3 , Deaprtmet Of Cardiology Platina Heart Hospital, Dhanashree Commercial Complex ,Dhantoli,Nagpur-440012
Nagpur
MAHARASHTRA |
9823026651
pramod_mundra@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jasleen Hospitals Ethics Committee Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cilacar |
10 mg , OD Oral for 30 days |
| Intervention |
Cilnidipine |
10 mg , OD Oral for 30 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change from baseline in sitting SBP and DBP on Day 30 (±4 days) in both treatment groups |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/03/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 |