A Study Metoprolol Succinate plus Cilnidipine plus Telmisartan Tablets in patients for treatment of uncontrolled essential hypertension with stable ischemic heart disease

Phase 3

Not yet recruiting

• Conditions: Chronic ischemic heart disease, unspecified,

• Registration Number: CTRI/2018/10/016182
• Lead Sponsor: Ajanta Pharma Ltd

Brief Summary

A Multicentric, Randomized, Double Blind, Parallel Group, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of FDC of Metoprolol Succinate ER 25 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets and FDC of Metoprolol Succinate ER 50 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets versus FDC of Metoprolol Succinate ER 50 mg plus Telmisartan 40 mg Tablets in patients of uncontrolled essential hypertension with stable ischemic heart disease.

 Primary Objective: To evaluate the efficacy and safety of FDC of Metoprolol Succinate ER 25 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets and FDC of Metoprolol Succinate ER 50 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets in patients of uncontrolled essential hypertension with stable ischemic heart disease.

 Secondary Objective: To evaluate the tolerability of FDC of Metoprolol Succinate ER 25 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets and FDC of Metoprolol Succinate ER 50 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets in patients of uncontrolled essential hypertension with stable ischemic heart disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-31
• Last Update Posted: 2018-12-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• 1.Male or female subjects aged between 18 and 65 years.
• 2.Subjects with the history of uncontrolled essential hypertension with stable ischemic heart disease [having seated diastolic BP (SeDBP) 90 to 110 mmHg and seated systolic BP (SeSBP) 140 to 180 mmHg] who is on the stable doses of Metoprolol Succinate ER 25 mg plus Telmisartan 40 mg Tablets for at least 4 weeks.
• 3.Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
• 4.Female subjects of childbearing potential must be willing to use acceptable method of contraception or post-menopausal for at least one year or surgically sterile.

Exclusion Criteria

• Subjects with any of the following conditions will be excluded from the study: 1.Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation.
• 2.Subjects with diagnosed Secondary or Malignant Hypertension.
• 3.Surgical or medical condition that, in the judgment of the Investigator or Sponsor, could interfere with absorption, distribution, metabolism, or excretion of the drugs to be used.
• 4.Cardiovascular system, Subjects with known case of symptomatic congestive heart failure, unstable angina pectoris, sinus node dysfunction and any clinically significant cardiac arrhythmias.
• Subject who has had myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery in last 1 year.
• Subjects with known case of stroke.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy and safety of FDC of Metoprolol Succinate ER 25 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets and FDC of Metoprolol Succinate ER 50 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets in patients of uncontrolled essential hypertension with stable ischemic heart disease	at the end of 12 weeks

Secondary Outcome Measures

Name	Time	Method
To evaluate the tolerability of FDC of Metoprolol Succinate ER 25 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets and FDC of Metoprolol Succinate ER 50 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets in patients of uncontrolled essential hypertension with stable ischemic heart disease	at the end of 12 weeks

Trial Locations

Locations (16)

All India Institute Of Medical Sciences; 🇮🇳 Jodhpur, RAJASTHAN, India

Apex Hospital Pvt. Ltd; 🇮🇳 Jaipur, RAJASTHAN, India

B. J Medical College & Civil Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Bansal Hospital & Research Centre; 🇮🇳 Jaipur, RAJASTHAN, India

Barala Hospital & Research Center; 🇮🇳 Jaipur, RAJASTHAN, India

Dr Ram Manohar Lohia Combined Hospital Lucknow; 🇮🇳 Lucknow, UTTAR PRADESH, India

Gandhi Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

GCS Medical College, Hospital and Research Centre; 🇮🇳 Ahmadabad, GUJARAT, India

Government Medical College and Super Specialty Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Institute of Post Graduate Medical Education and Research; 🇮🇳 Kolkata, WEST BENGAL, India

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All India Institute Of Medical Sciences

🇮🇳Jodhpur, RAJASTHAN, India

Dr Surender Deora

Principal investigator

8003996715

drsdeora@gmail.com