CTRI/2019/07/020204 [Registered on: 15/07/2019] Trial Registered Prospectively
Last Modified On:
28/01/2020
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study
A Study of Combination of Azilsartan Medoxomil plus Cilnidipine Tablets for the treatment of subjects with Hypertension.
Scientific Title of Study
A Multicentric, Randomized, Double Blind, Parallel Group, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of FDC of Azilsartan Medoxomil 40 mg plus Cilnidipine 5 mg Tablets and FDC of Azilsartan Medoxomil 40 mg plus Cilnidipine 10 mg Tablets versus Azilsartan Medoxomil Tablets 40 mg and Cilnidipine Tablets 10 mg monotherapy in subjects with stage 2 hypertension
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
CT-Syn-AC-2018, Version No. 2.0, Dated Nov 15, 2018
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Name
Dr A Gopal Rao
Designation
Associate Professor
Affiliation
Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital
Address
Department of Medicine,
Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital
Srikakulam-532001, Andhra Pradesh
Srikakulam ANDHRA PRADESH 532001 India
Phone
8942279033
Fax
Email
drgopalraoa@gmail.com
Details of Contact Person Scientific Query
Name
Abhinav Arora
Designation
Managing Director
Affiliation
Synokem Pharmaceuticals Ltd.
Address
Synokem Pharmaceuticals Ltd.
14/486, Sunder Vihar,
Outer Ring Road, Paschim Vihar,
New Delhi-110087, India.
New Delhi DELHI 110087 India
Phone
9811882440
Fax
Email
abhinavarora@synokempharma.com
Details of Contact Person Public Query
Name
Abhinav Arora
Designation
Managing Director
Affiliation
Synokem Pharmaceuticals Ltd.
Address
Synokem Pharmaceuticals Ltd.
14/486, Sunder Vihar,
Outer Ring Road, Paschim Vihar,
New Delhi-110087, India.
New Delhi DELHI 110087 India
Phone
9811882440
Fax
Email
abhinavarora@synokempharma.com
Source of Monetary or Material Support
Synokem Pharmaceuticals Ltd.
14/486, Sunder Vihar,
Outer Ring Road, Paschim Vihar,
New Delhi-110087, India.
Primary Sponsor
Name
Synokem Pharmaceuticals Ltd
Address
Synokem Pharmaceuticals Ltd.
14/486, Sunder Vihar,
Outer Ring Road, Paschim Vihar,
New Delhi-110087, India.
Bansal Hospital & Research Centre, 04, Janakpuri-1st, Imli Phatak, Jaipur-302005 Jaipur RAJASTHAN
9950442955
dr.ajayb.cr@gmail.com
Dr Swapnav Borthakur
Down Town Hospital Ltd.
Down Town Hospital Ltd.
Dispur, G S Road, Guwahati-781006 Kamrup ASSAM
9864038704
swapnav.borthakur@gmail.com
Dr D Anil Kumar
Gandhi Hospital
Department of General Medicine,
Gandhi Hospital, Musheerabad, Secunderabad-500003 Hyderabad TELANGANA
9440523902
anilddrmd@gmail.com
Dr Ansari Rizwanahmed Nurulhasan
GCS Medical College, Hospital and Research Centre
Department of Medicine,
GCS Medical College, Hospital and Research Centre,
Opp. DRM Office, Nr. Chamunda Bridge, Naroda Road, Ahmedabad-380025
Ahmadabad GUJARAT
9033884736
drrizwanansari@yahoo.com
Dr Krishna Chandra Narzary
GNRC Hospitals
GNRC Medical, North Guwahati-781031 Kamrup ASSAM
8133814975
drkrishna_narzary@yahoo.co.in
Dr Samir Govil
GSVM Medical College
Post Graduate Department of Medicine, GSVM Medical College, Kanpur-208002 Kanpur Nagar UTTAR PRADESH
9839068111
nephroknp@gmail.com
Dr Manoj Kumar Gupta
Health Point Hospital
21, Prannath Pandit Street (opp: Lansdown Padmapukur), Kolkata-700025 Kolkata WEST BENGAL
9599038676
manojsrmc@gmail.com
Dr Sanchita Saha
IPGME&R and SSKM Hospital
Department of Medicine, Arsenic Clinic, 4th Floor, Ronald Ross Building, IPGME&R and SSKM Hospital, 244, AJC Bose Road, Kolkata-700020 Kolkata WEST BENGAL
Rajendra Memorial Research Institute of Medical Sciences
Agamkuan, Patna-800007 Patna BIHAR
0612-2245744
drkrishnapandey@gmail.com
Dr A Gopal Rao
Rajiv Gandhi Institute of Medical Sciences & RIMS Government Genera! Hospital
Department of General Medicine, Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital, Srkakulam-532001 Srikakulam ANDHRA PRADESH
8942279033
drgopalraoa@gmail.com
Dr Sagar Vivek Redkar
Redkar Hospital and Research Centre
Redkar Hospital and Research Centre, Mumbai-Goa Highway, Oxelbag, Village-Dhargal, Tal-Pemem, Goa-403513 North Goa GOA
One tablet once a day orally in the morning after breakfast every day for 84 days (12 weeks)
Comparator Agent
Cilnidipine Tablets 10 mg
One tablet once a day orally in the morning after breakfast every day for 84 days (12 weeks)
Intervention
FDC of Azilsartan Medoxomil 40 mg plus Cilnidipine 10 mg Tablets
One tablet once a day orally in the morning after breakfast every day for 84 days (12 weeks)
Intervention
FDC of Azilsartan Medoxomil 40 mg plus Cilnidipine 5 mg Tablets
One tablet once a day orally in the morning after breakfast every day for 84 days (12 weeks)
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Male or female subjects aged between 18 and 65 years (both inclusive).
2. Treatment naïve subjects diagnosed with stage 2 hypertension having mean seated SBP of ≥160 to ≤180 mmHg and mean seated DBP ≥100 to ≤110 mmHg (3 readings will be taken by validated automated blood pressure machine in sitting position, first reading will be taken after 15 min. rest and subsequent two readings will be recorded at the interval of 2 min. each).
3. Subjects with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
4. Subjects willing to comply with the protocol requirements.
ExclusionCriteria
Details
1. Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation.
2. Any surgical or medical condition which might alter the absorption, distribution, metabolism or excretion of the study drug.
3. Has clinical laboratory evaluations (including biochemistry and hematology) are not within the reference range for the testing laboratory and the results are deemed clinically significant by the investigator.
4. Subjects with known case of secondary or malignant hypertension.
5. Subjects with evidence of postural hypotension (defined as drop in >20 mmHg for systolic blood pressure and >10 mmHg for diastolic blood pressure after assuming the standing posture from supine or sitting position).
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Sequentially numbered, sealed, opaque envelopes
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Mean change in seated systolic blood pressure (SeSBP) between baseline and 12 weeks. [For subjects who are discontinued due to lack of efficacy last SBP reading at the time of discontinuation will be considered as end point]
At Baseline, Week 2, Week 4, Week 8 and Week 12
Secondary Outcome
Outcome
TimePoints
Mean change in seated diastolic blood pressure (SeDBP) between baseline and 12 weeks. [For subjects who are discontinued due to lack of efficacy last DBP reading at the time of discontinuation will be considered as end point]
At Baseline, Week 2, Week 4, Week 8 and Week 12
Mean change in ambulatory blood pressure (Mean 24 hour SBP and DBP) from baseline to the end of study (12 weeks)
At baseline and Week 12
Target Sample Size
Total Sample Size="222" Sample Size from India="222" Final Enrollment numbers achieved (Total)= "228" Final Enrollment numbers achieved (India)="228"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
A Multicentric, Randomized, Double Blind, Parallel
Group, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safety
and Tolerability of FDC of Azilsartan Medoxomil 40 mg + Cilnidipine 5 mg
Tablets and FDC of Azilsartan Medoxomil 40 mg + Cilnidipine 10 mg Tablets
versus Azilsartan Medoxomil Tablets 40 mg and Cilnidipine Tablets 10 mg monotherapy
in subjects with stage 2 hypertension.
Primary objective:To evaluate the
efficacy and safety of FDC of Azilsartan
Medoxomil 40 mg + Cilnidipine 5 mg Tablets and FDC of Azilsartan Medoxomil 40 mg + Cilnidipine 10 mg Tablets
in subjects with stage 2 hypertension.
Secondary objective:To evaluate the
tolerability of FDC of Azilsartan
Medoxomil 40 mg + Cilnidipine 5 mg Tablets and FDC of Azilsartan Medoxomil 40 mg + Cilnidipine 10 mg Tablets
in subjects with stage 2 hypertension.