Health Condition 1: null- Patient having seated diastolic BP (SeDBP) 90 to 100 mmHg and seated systolic BP (SeSBP) 140 to 200 mmHg.
Conditions
Interventions
Intervention1: Fixed dose
combination of losartan
(50mg), amlodipine
(5mg) and
hydrochlorothiazide
(12.5mg): The recommended dosage is fixed dose combination of losartan (50mg), amlodipine (5mg) and
h
Sponsors
Sun Pharma Laboratories Limited SPLL
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patient aged between 18 and 70 years. 2. Patient had seated diastolic BP (SeDBP) 90 to 100 mmHg and seated systolic BP (SeSBP) 140 to 200 mmHg. 3. Patient who satisfied either (a) or (b). a. Patient who was on stable dose of FDC of Losartan 50mg and hydrochlorothiazide 12.5mg or FDC of Losartan 50mg and amlodipine 5mg at least 6 weeks as per historical record. b. New Patient or who was on stable dose of Losartan 50mg or Amlodipine 5mg or Hydrochlorothiazide 12.5mg. 4. Patient willingly gave informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant, lactating woman or woman of childbearing age who was not using an acceptable method of birth control. 2. Patient who was taking >=3 antihypertensive medications at the time of screening. 3. Patient who had history of treatment resistant hypertension, defined as BP >=140/90 mm Hg while taking triple-combination therapy (one of which was a diuretic) at the optimal dose of each drug. 4. Patient who had evidence of a secondary hypertension. 5. Patient who had significant heart disease (e.g., recent stroke/transient ischemic attack, heart failure, coronary artery bypass graft surgery, coronary intervention, angina pectoris, myocardial infarction, heart block, atrial fibrillation/flutter, or valve disease). 6. Patient who had type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus. 7. Patient who had significant pancreatic, renal or hepatic disease. 8. Patient who was hypersensitive to Losartan, Amlodipine or Hydrochlorothiazide. 9. Patient with anuria or hypersensitivity to other sulfonamide-derived drugs. 10. Patient with hepatic impairment who require titration with losartan. 11. Patient with or without a history of allergy or bronchial asthma. 12. Patient taking Lithium. 13. Patient using potassium supplements or salt substitutes containing potassium. 14. Patient who required or takes concomitant medications known to significantly affect BP.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy Variables: Percent average change from baseline to end of study in · Seated diastolic blood pressure (SeDBP). · Seated systolic blood pressure (SeSBP).Timepoint: - Visit 1: Baseline visit [Day 0] - Visit 2: Follow up visit [Week 4/Day 28 ± 2] -Visit 3: Follow up visit [Week 12/Day 84 ± 2] -Visit 4: End of study [Week 24/Day 168 ± 2] | — |
Secondary
| Measure | Time frame |
|---|---|
| SeDBP responder rate (No. of patients achieved SeDBP 90 mmHg). · SeSBP responder rate (No. of patients achieved SeSBP 140 mmHg). · Evaluation of CGI-S. · Evaluation of CGI-I.Timepoint: baseline, 4th week, 24 weeks | — |
Countries
India
Contacts
Public ContactMr Guruprasad Palekar
Sun Pharma Laboratories Limited
Outcome results
None listed