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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/10/016182

Enrollment

240

Registered

2018-10-29

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Metoprolol Succinate ER 25 mg plus Cilnidipine 10 mg plus Telmisartan 40 mg Tablets: Each tablet is to be taken orally with water in the morning after breakfast preferably on the same t

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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 diseaseTimepoint: at the end of 12 weeks	—

Secondary

Measure	Time frame
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 diseaseTimepoint: at the end of 12 weeks	—

Countries

India

Contacts

Public ContactDr Shailesh Singh

Ajanta Pharma Ltd

shailesh.singh@ajantapharma.com0226062111

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026