Treatment Optimisation for Blood Pressure With Single-Pill Combinations in India

Treatment Optimisation for Blood Pressure With Single-Pill Combinations in India

Hypertension is a leading cause of morbidity and mortality globally. Although multiple drugs are frequently used to treat it, in the South Asian context, evidence is lacking on best drug combinations. This trial aims to compare efficacy of three single-pill combinations of two anti-hypertensive agents on 24-hour ambulatory systolic blood pressure among 1968 individuals with hypertension. The trial is a single-blind randomized controlled trial spread across 37 hospitals in India.

Single Pill combinations (SPCs): 1) Amlodipine + Perindopril, 2) Perindopril + Indapamide, 3) Amlodipine + Indapamide

This is a multi-centre, individual randomized single-blind, parallel group, three-armed superiority trial to compare the efficacy of three different single-pill combinations of antihypertensive therapies (Amlodipine/Perindopril, Perindopril/Indapamide, and Amlodipine/Indapamide)on 24-hour ambulatory BP levels in Indians.

Inclusion Criteria:

1. Age 30-79 years AND
2. Sitting clinic values* of SBP ≥140 mmHg and <160 mmHg on one antihypertensive agent OR
3. Sitting clinic values* of SBP ≥150 mmHg and <180 mmHg on no antihypertensive treatment * Mean of the last 2 of 3 readings.

Exclusion Criteria:

1. Congestive heart failure (clinically defined).

2. Patients with a history of intolerance to any of the study medications for example angioedema or dry cough with Angiotensin-converting enzyme inhibitors.

3. Serum creatinine levels greater than 132.6µmol/l (1.5mg/dl)

4. 4. History of coronary heart disease (i.e., chronic stable angina, myocardial infarction or acute coronary syndrome).

5. History of a stroke or other cerebrovascular accident (i.e. transient ischaemic attack or reversible ischaemic neurological deficit).

6. Severe hepatic impairment

7. Treatment with agents causing torsades de pointes

8. Lactation

9. Contraindications to any of the investigational medicinal products as per the summaries product characteristics of drugs studied

10. Known or suspected secondary hypertension.

11. Any other concomitant illness, physical or mental impairment that could interfere with the effective conduct of the study.

12. Pregnancy or those of child-bearing age who are not taking reliable contraception.

13. History of Gout.

14. Serum potassium < 3.5mmol/L at screening.

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