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

A Comparative, Randomized, Double Blind, Multicentric, Active Controlled, Parallel Group, Two Arm, Phase III Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of Fimasartan Tablets Vs. Losartan Tablets in Patients with Mild Essential Hypertension

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/08/009242

Enrollment

240

Registered

2017-08-03

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: I10- Essential (primary) hypertension Health Condition 2: null- Mild Essential Hypertension

Interventions

Intervention1: Fimasartan Tablets 60 mg & 120 mg: One Tablet orally once daily in the morning for 90 days Control Intervention1: Losartan Tablets 50 mg and 100 mg: One Tablet orally once daily in the

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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

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 4. Serum potassium > 5.5 mEq/L or 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

Design outcomes

Primary

Measure	Time frame
Mean reduction in SBP and DBP from baseline to end of studyTimepoint: Day 7, 15, 30, 60 and 90	—

Secondary

Measure	Time frame
Mean change in Heart Rate from baseline to end of study.Timepoint: Day 7, 15, 30, 60 and 90	—

Countries

India

Contacts

Public ContactDr Shailesh Singh

Ajanta Pharma Ltd

shailesh.singh@ajantapharma.com2266062111

Outcome results

None listed

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