| CTRI Number |
CTRI/2010/091/003051 [Registered on: 22/12/2010] |
| Last Modified On: |
04/07/2011 |
| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
|
|
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the efficacy,safety and tolerability of Olmesartan Medoxomil 40mg + Amlodipine 10mg + Hydrochlorothiazide 25mg tablets in patient suffering from Hypertension. |
|
Scientific Title of Study
|
An open label, non comparative and multicentric clinical study to evaluate the efficacy, safety and tolerability of Olmesartan Medoxomil 40mg + Amlodipine 10mg + Hydrochlorothiazide 25mg tablets in patient suffering from Hypertension |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| VCP/CT/10/001 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Anand Nikalje |
| Designation |
|
| Affiliation |
|
| Address |
Apex Superspeciality Hospital,
6.7 Bassaye Nagar
Aurangabad
MAHARASHTRA
415570
India |
| Phone |
2326530 |
| Fax |
|
| Email |
anandnikalje@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr. Deepak Sohoni |
| Designation |
|
| Affiliation |
Project Coordinator |
| Address |
Bioscientific Research Laboratories (I) Pvt. Ltd.
BIOS HOUSE, Plot No. 106/3, Aries Compound, Opp. Thakur mall, S.V. Road, Mira road, Thane.
Mumbai
MAHARASHTRA
401104
India |
| Phone |
02228453582 |
| Fax |
02228453512 |
| Email |
deepaks@biosrl.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr. Deepak Sohoni |
| Designation |
|
| Affiliation |
|
| Address |
Bioscientific Research Laboratories (I) Pvt. Ltd.
BIOS HOUSE, Plot No 106/3, Aries Compound, Opp. Thakur mall, S.V. Road, Mira road, Thane.
Mumbai
MAHARASHTRA
401104
India |
| Phone |
02228453582 |
| Fax |
02228453512 |
| Email |
deepaks@biosrl.com |
|
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Source of Monetary or Material Support
|
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Primary Sponsor
|
| Name |
Vapi Care Pharma Pvt Ltd |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Anand Nikalje |
Apex Superspeciality Hospital |
6.7. Bassaye Nagar,-
Aurangabad
BIHAR |
(0240) 2326530
anandnikalje@rediffmail.com |
| Dr. Mahadev P Padhariya |
C.U Shah Medical Center |
C.J Hospital,Surendranagar-363001
|
9427664260
drmahadev_p@yahoo.co.in |
| Dr. Jignesh Gohel |
Pirmashayakh Sarvjanik Hospital |
Wankaner,-363621
|
9979887977
jignesh.gohel@yahoo.co.in |
| Dr. Suhas Rao |
Shree Venkatesha Hospital and Polyclinic |
A-Wing, Bably Apartment,Station Road, Nallasopara (W)-
|
250 3212611
drcrholambe@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Jagruti Ethics Committee |
Approved |
| Jagruti Ethics Committee |
Approved |
| Jagruti Ethics Committee |
Approved |
| Jagruti Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
In patients suffering from Hypertension, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Olmesartan Medoxomil 40mg + Amlodipine 10mg + Hydrochlorothiazide 25mg Tablets |
Once daily for 12 weeks. |
|
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
1.Patients of either gender between the age group of 18 to 75 years.
2.Patients suffering from hypertension.
(Systolic and Diastolic Blood Pressure more than 140/90mmHg respectively)
3.Written informed consent to participate to the trial.
|
|
| ExclusionCriteria |
| Details |
1.Patients with age of <18 or >75 years.
2.Pregnant or lactating woman.
3.History of hypersensitivity to the study drug or similar class of drug.
4.Significant history or presence of gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of common medications.
5.Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the test drug(s), including cardiovascular, renal, pulmonary, hepatic, gastrointestinal, endocrine/metabolic, haematological/oncological, neurological and psychiatric diseases.
6.Patients with serum creatinine greater than 2.5 mg/dl.
7.Patients with raised SGPT and total bilirubin greater than 50% above the upper normal limits
8.Any clinical significant illness during the 4 weeks prior to day 1 of this study.
9.Maintenance therapy with any drug, or history of drug dependency, alcohol abuse, or serious neurological or psychological disease.
10.Participation in a clinical trial with an investigation drug within 30 days proceeding day one of this study.
11.Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study.
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| 1. Seated Systolic Blood Pressure
2. Seated Diastolic Blood Pressure |
Day 1st, Week 2nd, Week 4th, Week 8th and Week 12th |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Headache, Dizziness, Blurred vision, Nausea and Vomiting, Chest pain, Breathlessness. |
Day 1st, Week 2nd, Week 4th, Week 8th and Week 12th. |
|
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Target Sample Size
|
Total Sample Size="200"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
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Phase of Trial
|
Phase 3 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
27/12/2010 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This is an open label, non comparative, multicentric clinical trial
to study the efficacy, safety and tolerability of Olmesartan Medoxomil 40mg + Amlodipine 10mg + Hydrochlorothiazide 25mg tablets in patients suffering from Hypertension. This trial will be conducted on 200 patients and it has four centres. The primary outcome measures are : Seated systolic blood pressure and Seated diastolic blood pressure. The secondary outcome measures are: Headache, Dizziness, Blurred vision, Nausea and Vomiting, Chest pain and Breathlessness. Both the primary outcome measures and secondary outcome measures will be assessed on Day 1st, week 2nd, Week4th, Week 8th and Week 12th. |