| CTRI Number |
CTRI/2010/091/000148 [Registered on: 06/04/2010] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
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A clinical trial to study the effects of two drugs, Fixed-Dose Combination of Telmisartan and Metoprolol Succinate ER with Telmisartan Alone in Patients of Essential Hypertension
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Scientific Title of Study
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An Open-labeled, Randomized, Parallel group, Active controlled, Multicentric Phase III Clinical trial to compare the efficacy, tolerability and Safety ofFixed-Dose Combination of Telmisartan and Metoprolol Succinate ER
with Telmisartan Alone in Patients of Essential Hypertension
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| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| DSCS/Raven/TelmiMet/0209A |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
Dr. Nitin m rathod |
| Designation |
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| Affiliation |
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| Address |
R N Cooper Hospital, Vileparle (W), Mumbai, nitinmr@Yahoo.in
Mumbai
MAHARASHTRA
400057
India |
| Phone |
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| Fax |
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| Email |
nitinmr@yahoo.in |
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Details of Contact Person
Scientific Query
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| Name |
Dr. Nitin m rathod |
| Designation |
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| Affiliation |
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| Address |
R N Cooper Hospital, Vileparle (W), Mumbai, nitinmr@Yahoo.in
Mumbai
MAHARASHTRA
400057
India |
| Phone |
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| Fax |
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| Email |
nitinmr@yahoo.in |
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Details of Contact Person
Public Query
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| Name |
Dr. Nitin m rathod |
| Designation |
|
| Affiliation |
|
| Address |
R N Cooper Hospital, Vileparle (W), Mumbai, nitinmr@Yahoo.in
Mumbai
MAHARASHTRA
400057
India |
| Phone |
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| Fax |
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| Email |
nitinmr@yahoo.in |
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Source of Monetary or Material Support
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| M/s. Ravenbhel Healthcare Pvt. Ltd. |
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Primary Sponsor
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| Name |
M/s. Ravenbhel Healthcare 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
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India |
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Sites of Study
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| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Rajiv R Oza |
Clinic, Bhavnagar, Rajivoza59@hotmail.com |
Clinic, Bhavnagar, Rajivoza59@hotmail.com,-
Bhavnagar
GUJARAT |
Rajivoza59@hotmail.com |
| Dr. Kirti C Patel |
K E M Hospital, Mumbai, pkirtic@yahoo.in |
K E M Hospital, Mumbai, pkirtic@yahoo.in,-
Mumbai
MAHARASHTRA |
pkirtic@yahoo.in |
| Dr. Nitin m rathod |
R N Cooper Hospital, Vileparle (W), Mumbai, nitinmr@yahoo.in |
R N Cooper Hospital, Vileparle (W), Mumbai, nitinmr@yahoo.in,-400057
Mumbai
MAHARASHTRA |
nitinmr@yahoo.in |
| Dr. Raj G Bhagat |
Smt. N H L Muni Medical college, Ahmedabad, rajpurvi@yahoo.com |
Smt. N H L Muni Medical college, Ahmedabad, rajpurvi@yahoo.com,-
Ahmadabad
GUJARAT |
rajpurvi@yahoo.com |
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Details of Ethics Committee
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| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| COMSARTs |
Approved |
| COMSARTs |
Approved |
| COMSARTs |
Approved |
| COMSARTs |
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 |
| Comparator Agent |
telmisartan |
once daily |
| Intervention |
Telmisartan with metoprolol ER |
once daily` |
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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 |
? Male and female outpatients ³ 18 years of age.
? Females must be either irreversibly sterilized or post-menopausal as defined by the absence of menstruation for at least 24 months.
? Essential hypertensive patients who meet the following criteria.
o Mean supine DBP >= 95 and <= 114 mm Hg at each of Visits 2 and 3.
o Mean supine systolic blood pressure (SBP) must be >= 140 and <= 200 mm Hg at Visit 3.
? Able to stop current antihypertensive therapy without risk to the patient.
? Patients who are able and are willing to comply with the protocol and have signed IEC or IRB approved Informed Consent Form.
? Patients who are able to adequately maintain the diary.
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| ExclusionCriteria |
| Details |
? Not willing to sign the ICF,
? Known or suspected secondary hypertension.
? Mean SBP equal to or greater than 200 mmHg
? Patients with abnormal clinical chemistry, hematology, urinalysis, or ECG test results that are considered clinically significant by the investigator or the sponsor.
? Patients with significant hepatic disease (liver function tests x 2 upper limit of normal reference range) or significant renal disease (creatinine x 2 upper limit of normal reference range).
? Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients post-renal transplant or with only one functioning kidney
? Uncorrected volume or sodium depletion or hyponatremia
? Primary aldosteronism
? Hereditary fructose intolerance
? Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists
? History of drug or alcohol dependency within the previous six months. Chronic administration of any medication known to affect blood pressure, other than the trial medication
? Concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form.
? Symptomatic congestive heart failure (New York Heart Academy (NYHA) functional class CHF II-IV) - unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery less than three months prior to informed consent
? Stroke less than six months prior to informed consent
? Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant arrhythmias as determined by the investigator.
? Hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve
? Insulin-dependent diabetes mellitus whose diabetes has not been stable and controlled for the previous three months
? Night-shift workers who routinely sleep during the daytime and whose working hours include midnight to 4: 00 AM
? Known allergic hypersensitivity to any component of the formulations under investigation
? Concomitant therapy with lithium, cholestyramine or colestipol resins. non-compliance with study medication (defined as less than 80% or more than 120%) during the run-in period
? Current treatment with any antihypertensive agent
? Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan or Metoprolol
? Patients being treated with any of the excluded medications mentioned in the protocol.
? Patients with concomitant diseases such as malignancy, HIV
? Pregnancy and lactation.
? Females of childbearing potential may not be recruited.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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On-site computer system |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| To investigate whether a fixed-dose combination of 20 mg of the angiotensin receptor II antagonist telmisartan plus 25 mg of the beta-blocker Metoprolol Succinate ER is superior to 20 mg telmisartan alone in patients with mild to moderate hypertension. |
8 weeks |
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Secondary Outcome
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Target Sample Size
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Total Sample Size="200"
Sample Size from India=""
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 3 |
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Date of First Enrollment (India)
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Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/02/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="0"
Months="2"
Days="0" |
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Recruitment Status of Trial (Global)
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Completed |
| Recruitment Status of Trial (India) |
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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 An Open-labeled, Randomized, Parallel group, Active controlled, Multicentric
Phase III Clinical trial to compare the efficacy, tolerability and Safety of Fixed-Dose Combination of Telmisartan and Metoprolol Succinate ER with Telmisartan Alone in Patients of Essential Hypertension in 200 patients will be conducted in 4 centres in India
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