A Clinical study to evaluate the Efficacy, Safety of Fimasartan Tablets Vs Losartan Tablets in Patients with Mild Essential Hypertension.

Phase 3

Completed

• Conditions: Essential (primary) hypertension, Mild Essential Hypertension,

• Registration Number: CTRI/2017/08/009242
• Lead Sponsor: Ajanta Pharma Ltd

Brief Summary

This is a Comparative, Randomized, Double Blind,Multicentric, Active Controlled, Parallel Group, Two Arm, Phase III ClinicalTrial to Evaluate the Efficacy, Safety and Tolerability of Fimasartan TabletsVs. Losartan Tablets in Patients with Mild Essential Hypertension. PrimaryOutcome of the study is to study the mean reduction of SBP and DBP inhypertensive patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-09
• Study Completion: 2018-10-05
• Last Update Posted: 2018-11-24

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Patients diagnosed with Hypertension with SBP 140 to 159 mmHg and DBP 90 to 99 mmHg 2.
• Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.

Exclusion Criteria

• 1.Patients diagnosed with Moderate to Severe Hypertension (defined as a SBP ≥160 mmHg and DBP ≥100 mmHg) as defined by 6th report of JNC on Prevention, Detection, Evaluation Treatment of High Blood Pressure.
• 2.Subjects who are on any other antihypertensive or diuretic drugs.
• 3.Patients with severe renal impairment (eGFR ≤ 30ml/min).
• 4.Serum potassium > 5.5 mEq/L or < 3.0 mEq/L at baseline.
• 5.Patients with hepatic impairment [SGOT, SGPT and S.
• Bilirubin (total) ≥ 2 times the upper limit of normal reference values].
• 6.Patients with clinical ASCVD defined as Obstructive coronary artery disease, peripheral vascular disease and Cerebrovascular disease 7.Patients who have undergone Percutaneous Transluminal Coronary Angiography (PTCA), and Coronary Artery Bypass Graft (CABG).
• 8.Patients with structural heart disease like hypertrophic obstructive cardiomyopathy, hemodynamically significant aortic valve or mitral valve disease, Pericardial diseases & CHF of any etiology.
• 9.Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia.
• 10.Patient with history of Type I or Type II Diabetes Mellitus.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean reduction in SBP and DBP from baseline to end of study	Day 7, 15, 30, 60 and 90

Secondary Outcome Measures

Name	Time	Method
Mean change in Heart Rate from baseline to end of study.	Day 7, 15, 30, 60 and 90

Trial Locations

Locations (22)

Andhra Medical College & King George Hospital; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

Apex Heart Institute; 🇮🇳 Ahmadabad, GUJARAT, India

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

B. J. Government Medical College & Sassoon General Hospital; 🇮🇳 Pune, MAHARASHTRA, India

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

Brij Medical Centre; 🇮🇳 Nagar, UTTAR PRADESH, India

Eternal Heart Care Centre & Research Institute Pvt. Ltd; 🇮🇳 Jaipur, RAJASTHAN, India

Gandhi Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Grant Government Medical College and Sir J.J Group of Hospitals; 🇮🇳 Mumbai, MAHARASHTRA, India

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

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Andhra Medical College & King George Hospital

🇮🇳Visakhapatnam, ANDHRA PRADESH, India

Dr K Padmalatha

Principal investigator

9246620072

padmalathamdgen@gmail.com