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

Treatment Optimisation for blood Pressure with Single-Pill combinations in India - TOPSPIN

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/04/042106

Enrollment

1968

Registered

2022-04-22

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I10- Essential (primary) hypertension

Interventions

Intervention1: Arm 1: (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 Tre

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age30-79 years AND 2.Sitting clinic values (mean of the last 2 of 3 readings) of SBP = 140mmHg and 3.Sitting clinic values (mean of the last 2 of 3 readings) of SBP = 150mmHg and

Exclusion criteria

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.

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactKavita Singh

Centre for Chronic Disease Control

kavita@ccdcindia.org

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026