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

Phase 3

• Conditions: Health Condition 1: I259- Chronic ischemic heart disease, unspecified

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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