Date

2020-05-22

Protocol

Protocol changed

Item Changed

Intervention(s) planned - Study Sites

Previous Version

1. Study sites • National Hospital of Sri Lanka • Sri Jayewardenepura General Hospital • Colombo North Teaching Hospital, Ragama • Kurunegala Teaching Hospital • Peradeniya Teaching Hospital • Kandy Teaching Hospital • Colombo South Teaching Hospital 2. Method of randomization: via a secure web-based internet system. The randomization ratio will be 1:1, and will be stratified to ensure balance in prognostic factors: country of recruitment, age (<65 vs. >65 years) and average of 2 recorded baseline systolic BP measurements (<140 vs >140mmHg). 3. The double-blind period will be preceded by a single-blind (participants will remain blind), active run-in phase to ensure tolerability and adherence of the regimen. This will last a minimum of 2 weeks and may be extended for a further 2 weeks if the first period was interrupted, problematic or another reason (maximum 4 weeks run-in phase) 4. All randomized participants will receive study medication for an average of three years. 5. Interventions Experimental arm: Triple Pill (active treatment) telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg. 1 capsule taken orally once daily for 36 months 6. Placebo Comparator: Placebo Received via blinded study capsules. 1 capsule taken orally once daily for 36 months

Next Version

1. Study sites • National Hospital of Sri Lanka • Sri Jayewardenepura General Hospital • Colombo North Teaching Hospital, Ragama • Kurunegala Teaching Hospital • Peradeniya Teaching Hospital • Kandy Teaching Hospital • Colombo South Teaching Hospital • Jaffna Teaching Hospital • Karapitiya Teaching Hospital 2. Method of randomization: via a secure web-based internet system. The randomization ratio will be 1:1, and will be stratified to ensure balance in prognostic factors: country of recruitment, age (<65 vs. >65 years) and average of 2 recorded baseline systolic BP measurements (<140 vs >140mmHg). 3. The double-blind period will be preceded by a single-blind (participants will remain blind), active run-in phase to ensure tolerability and adherence of the regimen. This will last a minimum of 2 weeks and may be extended for a further 2 weeks if the first period was interrupted, problematic or another reason (maximum 4 weeks run-in phase) 4. All randomized participants will receive study medication for an average of three years. 5. Interventions Experimental arm: Triple Pill (active treatment) telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg. 1 capsule taken orally once daily for 36 months 6. Placebo Comparator: Placebo Received via blinded study capsules. 1 capsule taken orally once daily for 36 months