Treatment Optimisation for Blood Pressure With Single-Pill Combinations in India (TOPSPIN)
Primary Hypertension
About this trial
This is an interventional other trial for Primary Hypertension
Eligibility Criteria
Inclusion Criteria: Age 30-79 years AND Sitting clinic values* of SBP ≥140 mmHg and <160 mmHg on one antihypertensive agent OR Sitting clinic values* of SBP ≥150 mmHg and <180 mmHg on no antihypertensive treatment * Mean of the last 2 of 3 readings. Exclusion Criteria: Congestive heart failure (clinically defined). Patients with a history of intolerance to any of the study medications for example angioedema or dry cough with Angiotensin-converting enzyme inhibitors. Serum creatinine levels greater than 132.6µmol/l (1.5mg/dl) 4. History of coronary heart disease (i.e., chronic stable angina, myocardial infarction or acute coronary syndrome). History of a stroke or other cerebrovascular accident (i.e. transient ischaemic attack or reversible ischaemic neurological deficit). Severe hepatic impairment Treatment with agents causing torsades de pointes Lactation Contraindications to any of the investigational medicinal products as per the summaries product characteristics of drugs studied Known or suspected secondary hypertension. Any other concomitant illness, physical or mental impairment that could interfere with the effective conduct of the study. Pregnancy or those of child-bearing age who are not taking reliable contraception. History of Gout. Serum potassium < 3.5mmol/L at screening. -
Sites / Locations
- Lalitha Super Specialities HospitalRecruiting
- Apollo-Excelcare HospitalRecruiting
- All India Institute of Medical SciencesRecruiting
- Rudraksha HospitalRecruiting
- SDM College of Medical Sciences & HospitalRecruiting
- JSS HospitalRecruiting
- Lisie HospitalRecruiting
- Lakshmi HospitalRecruiting
- Sengupta Hospital & Research InstituteRecruiting
- North Eastern Indira Gandhi Regional Institute of Medical SciencesRecruiting
- Dayanand Medical College and HospitalRecruiting
- All India Institute of Medical SciencesRecruiting
- Madras Medical CollegeRecruiting
- Sri Ramchandra Institute of Higher Education and ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Arm 1
Arm 2
Arm 3
(Arm 1 compare to Arm 2 compare to Arm 3) - Treatment Period 1 (Enrollment - 2 months) - Single Pill Combination of Amlodipine 5 mg and Perindopril 4 mg once daily, orally Treatment Period 2 (2 months - 6 months) - Single Pill Combination of Amlodipine 10 mg and Perindopril 8 mg once daily, orally
(Arm 1 compare to Arm 2 compare to Arm 3) - Treatment Period 1 (Enrollment - 2 months) - Single Pill Combination of Perindopril 4 mg and Indapamide 1.25 mg once daily, orally Treatment Period 2 (2 months - 6 months) - Single Pill Combination of Perindopril 8 mg and Indapamide 2.5 mg once daily, orally
(Arm 1 compare to Arm 2 compare to Arm 3) - Treatment Period 1 (Enrollment - 2 months) - Single Pill Combination of Amlodipine 5 mg and Indapamide 1.5 mg sustained release once daily, orally Treatment Period 2 (2 months - 6 months) - Single Pill Combination of Amlodipine 10 mg and Indapamide 1.5 mg sustained release once daily, orally