CTRI/2019/01/016858 [Registered on: 03/01/2019] Trial Registered Prospectively
Last Modified On:
11/11/2019
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
A clinical trial to study the effects of three drugs, Olmesartan Medoxomil, Chlorthalidone and Cilnidipine Tablet in treatment of essential high blood pressure in India
Scientific Title of Study
A multicentric, open label study to evaluate safety and efficacy of fixed dose combination of Olmesartan Medoxomil, Chlorthalidone and Cilnidipine Tablet in the treatment of essential hypertension in India
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
ICR/17/002, Version 2.0 dated 03/MAY/2018
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Nomita Bhandari
Designation
General Manager- India Clinical Research
Affiliation
Sun Pharma Laboratories Limited (SPLL)
Address
Sun House
Plot No.201, B/1, Western Express Highway, Goregaon(E),
Mumbai
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243245397
Fax
02228947101
Email
nomita.bhandari@sunpharma.com
Details of Contact Person Scientific Query
Name
Dr Maulik Doshi
Designation
Medical Monitor
Affiliation
Sun Pharma Laboratories Limited (SPLL)
Address
Tandalja, Vadodara
Vadodara GUJARAT 390020 India
Phone
02656615500
Fax
02652354897
Email
maulik.doshi@sunpharma.com
Details of Contact Person Public Query
Name
Guruprasad Palekar
Designation
Operational Manager
Affiliation
Sun Pharma Laboratories Limited (SPLL)
Address
Sun House,
Plot No.201 B/1, Western Express Highway,
Goregaon (E), Mumbai
Mumbai (Suburban) MAHARASHTRA 400 063 India
Phone
02243245215
Fax
0222894701
Email
guruprasad.palekar@sunpharma.com
Source of Monetary or Material Support
Sun Pharma Laboratories Limited
Sun House,
Plot No.201 B/1, Western Express Highway,
Goregaon ( E),Mumbai 400 063, Maharashtra, India
Primary Sponsor
Name
Sun Pharma Laboratories Limited
Address
Sun House,
Plot No.201 B/1, Western Express Highway,
Goregaon ( E),Mumbai 400 063, Maharashtra, India
FDC of Olmesartan Medoxomil (20 mg), Chlorthalidone (12.5 mg) and Cilnidipine (10 mg) tablet
Manufacturer: Sun Pharma Laboratories Limited (SPLL)
One tablet to be taken once a day after breakfast
Intervention
FDC of Olmesartan Medoxomil (40 mg), Chlorthalidone (12.5 mg) and Cilnidipine (10 mg) tablet
Manufacturer: Sun Pharma Laboratories Limited (SPLL)
One tablet to be taken once a day after breakfast
Comparator Agent
Not Applicable as it is single arm trial
Not Applicable as it is single arm trial
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Male or female patient aged between 18 and 65 years (both inclusive)
2.Patient having seated diastolic BP (SeDBP) 90 to 110 mm of Hg (both inclusive) and seated systolic BP (SeSBP) 140 to 200 mm of Hg (both inclusive)
3. Patient who is on stable dose of either of the following dual therapy (as a FDC or individual drugs) for at least 4 weeks before screening as per historical record
a) Olmesartan 20 mg/ 40 mg and Chlorthalidone 12.5 mg or
b) Olmesartan 20 mg/ 40 mg and Cilnidipine 10 mg or
c) Cilnidipine 10 mg and Chlorthalidone 12.5 mg
4.Patient willing to give informed consent
5.Female patient of childbearing potential must be willing to use acceptable method of contraception (female of childbearing potential is defined as one who has not been postmenopausal for at least one year, or has not been surgically sterilized, or has not had a hysterectomy at least three months prior to the start of this study). Acceptable method of contraception includes (e.g. barrier method with spermicide). The "calendar method," withdrawal, or an IUD is NOT an acceptable method
ExclusionCriteria
Details
1.Pregnant or lactating woman
2.Surgical or medical condition that, in the judgment of the Investigator or Sponsor, (e.g. cholecystectomy) could interfere with absorption, distribution, metabolism, or excretion of the investigational products to be used
3.Current or past history of :
a)Significant heart disease (e.g. stroke/ transient ischemic attack, heart failure, tachycardia (pulse rate > 100 beats/ min), coronary artery bypass graft surgery, coronary intervention, angina pectoris, myocardial infarction, heart block, atrial fibrillation/ flutter, hypertensive encephalopathy or valve disease)
b)Other clinically significant conditions including but not limited to: pulmonary, central nervous system, thyroid, pancreatic, hepatic or renal disease (eGFR less than 60 ml/min/ 1.73m2)
4.Patient with type 2 diabetes (HbA1c greater than or equal to 7.5%)
5.Patient who is hypersensitive to study medications or any of its components
6.Current or recent substance abuse, including alcohol (as per DSM-5)
7.Participation in any experimental drug study within 60 days before screening
8.Patient who requires or takes concomitant medications (e.g. RAS inhibitors and Aliskiren) known to significantly affect BP
9.Patient judged unfit for this study by investigator (E.g. History of HIV and/ or Hepatitis B and/ or Hepatitis C)
10.Investigator, study personnel, sponsor representatives and their first degree relatives
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Safety
•Proportion of participants with adverse events and serious adverse events
12 weeks
Secondary Outcome
Outcome
TimePoints
Mean change in Seated Diastolic Blood Pressure (SeDBP) from baseline
4, 8 and 12 weeks
Mean change in Seated Systolic Blood Pressure (SeSBP) from baseline
4, 8 and 12 weeks
Proportion of patients achieving SeDBP less than 90 mm of Hg (SeDBP responder)
4, 8 and 12 weeks
Proportion of patients achieving SeSBP less than 140 mm of Hg (SeSBP responder)
4, 8 and 12 weeks
Target Sample Size
Total Sample Size="330" Sample Size from India="330" 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 4
Date of First Enrollment (India)
31/01/2019
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="2" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
None Yet
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This is a multicentric, open label study to evaluate safety and efficacy of fixed dose combination of
Olmesartan Medoxomil, Chlorthalidone and Cilnidipine Tablet in the treatment of
essential hypertension in India. A cohort of 330 patients will be adequate and
feasible to provide all safety and efficacy related data for 300 evaluable
patients. Total study duration will be of 14 weeks which includes 2
weeks of screening period and 12 weeks of treatment period.
Study includes 05 visits. Patient who is on stable
dose of dual therapy (as a FDC or individual drugs of Olmesartan 20
mg/ 40 mg and Chlorthalidone 12.5 mg or Olmesartan 20 mg/ 40 mg and Cilnidipine
10 mg or Cilnidipine 10 mg and Chlorthalidone 12.5 mg for at least 4 weeks before screening
will be provided with study medication. The dose can be increased for patients whose
SeSBP greater than or equal to140 mm of Hg and/ or SeDBP greater than
or equal to 90 mm of Hg and who receive Olmesartan Medoxomil
(20mg), Chlorthalidone (12.5 mg) and Cilnidipine (10 mg) tablet to Olmesartan Medoxomil (40 mg), Chlorthalidone
(12.5 mg) and Cilnidipine (10 mg) tablet and the dose can be decreased for
tolerability reasons based on investigator’s discretion in the subsequent visits. Safety assessments will include physical and
vital signs examination, clinical laboratory estimation and evaluation of adverse
events/ serious adverse events (if any). Efficacy assessments will be
done during the study. Mean change in Seated Diastolic and
Systolic Blood Pressure (SeDBP)/ (SeSBP) at week 4, 8 and 12 from baseline will
be analyzed. Responder (proportion of patients
achieving SeDBP < 90 mm Hg and proportion of patients achieving SeSBP
< 140 mm Hg) will be estimated and analyzed at week 4, 8 and 12.