| CTRI Number |
CTRI/2011/07/001879 [Registered on: 13/07/2011] Trial Registered Prospectively |
| Last Modified On: |
16/07/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
|
Drug |
| Study Design |
Other |
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Public Title of Study
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To find out the effectiveness and safety of a fixed-dose combination of perindopril 4mg & amlodipine 5 mg in reducing both the peripheral blood pressure (measured by a simple BP instrument) and aortic blood pressure (measured by a non-invasive instrument) in daily clinical practice |
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Scientific Title of Study
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Evaluation of effect of Coversyl-AM on Peripheral and Central Aortic Blood Pressure In Daily Clinical Practice |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| IC4-9490-99-IND |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
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| Name |
Dr Ajaykumar Yadav |
| Designation |
Clinical Project Manager |
| Affiliation |
|
| Address |
Serdia Pharmaceuticals India Pvt. Ltd., Serdia House, Off Dr. S. S. Rao road, behind M.G.M. Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
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| Fax |
|
| Email |
ajaykumar.yadav@in.netgrs.com |
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Details of Contact Person
Public Query
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| Name |
Dr Manjusha Rajarshi |
| Designation |
Head of Regulatory Affairs & Clinical Research Department |
| Affiliation |
|
| Address |
Serdia Pharmaceuticals India Pvt. Ltd., Serdia House, Off Dr. S. S. Rao road, behind M.G.M. Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
manjusha.rajarshi@in.netgrs.com |
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Source of Monetary or Material Support
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| Serdia Pharmaceuticals (India) Pvt. Ltd. |
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Primary Sponsor
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| Name |
Serdia Pharmaceuticals India Pvt Ltd |
| Address |
Serdia House, Off Dr. S. S. Rao road, behind M.G.M. Hospital, Parel, Mumbai - 400012 |
| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr N Sivakadaksham |
Sivas Cardio Care Clinic |
19, Deivaigamani Street, (Near Music Academy) Royapettah, Chennai - 600014
Chennai
TAMIL NADU |
044-28111309
drnsiva@gmail.com |
| Dr Thanikachalam |
Sri Ramachandra Medical Center |
Sri Ramachandra Medical Center, Sri Ramachandra University Campus, Porur, Chennai - 600116
Chennai
TAMIL NADU |
91-44-24766991
stsrmc@yahoo.com |
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Details of Ethics Committee
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| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Clinical Ethics Forum Mumbai |
Approved |
| Sri Ramachandra University |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Hypertension, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Coversyl-AM (Fixed-dose combination of Perindopril 4 mg & Amlodipine 5 mg) |
All the enrolled patients will take one tablet of Coversyl-AM (a fixed-dose combination of Perindopril 4 mg & Amlodipine 5 mg) orally once daily in the morning. The dose can be increased to a maximum of 2 tablets of Coversyl-AM orally once daily in the morning, based on patient’s clinical condition. All the enrolled patients will take Coversyl_AM for the total study duration of 1 year. |
| Comparator Agent |
Not Applicable |
Not Applicable |
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Inclusion Criteria
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| Age From |
40.00 Year(s) |
| Age To |
79.00 Year(s) |
| Gender |
Both |
| Details |
• Male and female patients between 40 years to 79 years of age
• Hypertensive patients who is either:
a. Newly diagnosed, untreated moderate to severe hypertensive patients with SBP≥160 mm Hg and /or DBP≥100 mm Hg
b. Patients inadequately controlled (SBP≥140 mm Hg and /or DBP ≥90 mm Hg) on monotherapy
c. Patients inadequately controlled (SBP≥140 mm Hg and /or DBP ≥90 mm Hg) on any other combination therapy (given separately or as fixed-dose combination)
• Given written informed consent to participate in the study and agree for regular follow-up |
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| ExclusionCriteria |
| Details |
• Previous myocardial infarction
• Presently treated angina
• Cerebrovascular event within the previous 3 months
• Uncontrolled arrhythmia
• Heart failure
• Severe hepatic/ renal abnormalities
• Galactosemia
• Any contraindication to an ACE inhibitor and/or CCB
• Any clinically important hematological or biochemical abnormality
• Pregnancy/ Lactation
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
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Not Applicable |
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Primary Outcome
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| Outcome |
TimePoints |
| Reduction of peripheral & central aortic blood pressure from baseline to end of study |
Month 0, Month 3, Month 6, Month 9 & Month 12 |
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Secondary Outcome
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| Outcome |
TimePoints |
| Safety profile |
Month 0, Month 3, Month 6, Month 9 & Month 12 |
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Target Sample Size
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Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 4 |
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Date of First Enrollment (India)
|
01/08/2011 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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This study is proposed to evaluate the effect of fixed combination of amlodipine-perindopril on peripheral as well as central aortic pressures in ’real world’ daily clinical setting in India.
It is an open-label, prospective, non-comparative, phase-IV study planned to be conducted in 200 hypertensive patients in 2 centers. The treatment duration is for a period of 1 year and includes 5 visits (including the inclusion and end of study visit). |