Treatment Optimisation for Blood Pressure with Single-Pill combinations in India

Phase 4

Completed

• Conditions: Health Condition 1: I10- Essential (primary) hypertension

• Registration Number: CTRI/2022/04/042106
• Lead Sponsor: Imperial College

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1981

Inclusion Criteria

1.Age30-79 years AND

2.Sitting clinic values (mean of the last 2 of 3 readings) of SBP = 140mmHg and <160mmHg on one antihypertensive agent OR

3.Sitting clinic values (mean of the last 2 of 3 readings) of SBP = 150mmHg and < 180mmHg on no antihypertensive treatment

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 ACE--inhibitors.

3. 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).

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 SmPc 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
24-hour ABPM (ambulatory blood pressure monitoring) to measure ambulatory systolic blood pressure.Timepoint: 2, 4, 6 months

Secondary Outcome Measures

Name	Time	Method
1. ADBP (24-hour ambulatory diastolic blood pressure)a t 6 months adjusted for baseline ADBP <br/ ><br>2. Clinic BP <br/ ><br>3. Day-time and night-time BP <br/ ><br>4. BP variability <br/ ><br>5. Proportion of patients who achieve BP control <br/ ><br>6. Proportion of patients classified as responders ? <br/ ><br>7. Micro-albuminuria <br/ ><br>8. Fasting blood glucose concentration <br/ ><br>9. Fasting lipid profile <br/ ><br>10. Serum sodium, potassium, urea, uric acid, creatinine and eGFRTimepoint: 2, 4, 6 months