A Multicentric Randomized Double Blind Double Dummy Parallel Group Comparative Phase III Clinical Study to Evaluate the Efficacy Safety and Tolerability in subjects with Uncontrolled Essential Hypertension with stable Coronary Artery Disease (CAD).

Phase 3

Not yet recruiting

• Conditions: Essential (primary) hypertension,

• Registration Number: CTRI/2022/11/047055
• Lead Sponsor: Ajanta Pharma Limited

Brief Summary

A Multicentric, Randomized, Double Blind, Double Dummy, Parallel Group, Comparative, Phase-III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of FDC of Metoprolol succinate 50 mg + Amlodipine 5 mg + Telmisartan 40 mg tablets, versus Co-administration of Metoprolol succinate 50 mg and Telmisartan 80 mg tablets in subjects with Uncontrolled Essential Hypertension with stable Coronary Artery Disease (CAD)

Trial of 84 days with two arms

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-11
• Last Update Posted: 2022-12-13

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• 1.Male or female subjects aged between 18 and 75 years.
• 2.Subjects of stable coronary artery disease.
• 3.Subjects with the history of uncontrolled essential hypertension with stable coronary artery disease [having seated diastolic BP (SeDBP) 90 to 110 mmHg and seated systolic BP (SeSBP) 140 to 180 mmHg] who is on the stable dose of Metoprolol succinate ER 50 mg plus Telmisartan 40 mg Tablets for at least 4 weeks.
• 4.Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
• 5.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

• 1.Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation.
• 2.Subjects with EF less than 40% as per Simpson’s method on 2D Echo.
• 3.Subjects diagnosed with Secondary or Malignant Hypertension.
• 4.Surgical or medical condition that, in the judgment of the Investigator, could interfere with absorption, distribution, metabolism, or excretion of the drugs to be used.
• 5.Renal system: Subjects with eGFR more than 60 mL per min per 1.73m2 Subjects with abnormal lab values of Na, K, Mg and Uric acid.
• normal range: Na Equal to135 to 145 mEq per L, K equal to 3.5 to 5.0 mmol per L, Mg equal to 7 to 12 mg per dL and Uric acid 3.5 to 7.2 mg per dL 6.Hepatic system: Subjects with abnormal Liver Function Test with values more than 2.5 times the upper limit of normal.
• 7.Endocrine system: Subjects with abnormal Thyroid Function Test, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus with HbA1c value greater than 8%.
• 8.Cardiovascular system: Subjects with known case of symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) less than one year or coronary artery bypass graft (CABG) surgery less than one year, sinus node dysfunction and any clinically significant cardiac arrhythmias.
• Subjects with known case of Stroke.
• 9.Other disease conditions Subject with clinical history of COPD, Bronchial Asthma and Peripheral Vascular disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change in SeSBP between baseline and 12 weeks.	Baseline and 12 weeks
The assessment of safety of subjects, comparison of incidence of treatment emergent adverse event (TEAE).	Baseline and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Mean change in SeDBP from baseline Time frame: 4, 8 and 12 weeks.	Mean change in SeSBP from baseline Time frame: 4, 8 and 12 weeks.

Trial Locations

Locations (11)

Aartham Multi Super Speciality Hospital, Ahmedabad; 🇮🇳 Ahmadabad, GUJARAT, India

Government Medical College and Govt General Hospital, Srikakulam; 🇮🇳 Srikakulam, ANDHRA PRADESH, India

GSVM Medical College, Kanpur; 🇮🇳 Nagar, UTTAR PRADESH, India

IPGME and R; 🇮🇳 Kolkata, WEST BENGAL, India

Jawahar Lal Nehru Medical College Ajmer; 🇮🇳 Ajmer, RAJASTHAN, India

KHIMS Hospital, Kanpur; 🇮🇳 Nagar, UTTAR PRADESH, India

King George Hospital, Vishakapatnam; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

Lifeline Multispeciality Hospital, Mumbai; 🇮🇳 Mumbai, MAHARASHTRA, India

Medical college and hospital, Kolkata; 🇮🇳 Kolkata, WEST BENGAL, India

Motilal Nehru Medical College, Allahabad; 🇮🇳 Allahabad, UTTAR PRADESH, India

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Aartham Multi Super Speciality Hospital, Ahmedabad

🇮🇳Ahmadabad, GUJARAT, India

Dr Kuntal Shah

Principal investigator

8980075065

kuntalshah64@gmail.com