Clinical trial NCT05683301: Treatment Optimisation for Blood Pressure With Single-Pill Combinations in India
Official title: Treatment Optimisation for Blood Pressure With Single-Pill Combinations in India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Primary Hypertension
Lead sponsor: Centre for Chronic Disease Control, India
Sponsor class: OTHER
Collaborators: name: All India Institute of Medical Sciences
name: Imperial College London
First posted: 2023-01-13
Enrollment: 1981
Sex: ALL
Minimum age (years): 30
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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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Primary outcomes:
measure: 24-hour ambulatory systolic Blood Pressure
timeFrame: Change in between baseline and 6 month Ambulatory Systolic Blood Pressure
Secondary outcomes:
measure: 24-hour ambulatory diastolic blood pressure
timeFrame: Change in between baseline and 6 month Ambulatory Diastolic Blood Pressure
measure: Clinic Blood Pressure
timeFrame: Comparison of Clinic blood pressure measured at baseline 2 month , 4 month and 6 month
measure: Daytime and nighttime Blood Pressure
timeFrame: Change in between baseline and 6 month ASBP and ADBP
measure: BP variability measured by ABPM and within-visit clinic BPs
timeFrame: Fluctuations in Ambulatory blood pressures as measured at baseline and 6 month and fluctuation in Clinic BP as measured at baseline, 2 month, 4 month and 6 month
measure: Proportion of patients who achieve BP control
timeFrame: BP control measured in Clinic BP as measured at baseline, 2 month, 4 month and 6 month and ABP measured at baseline and 6 month
measure: Proportion of patients classified as "responders"
timeFrame: Clinic BP as measured at baseline, 2 month, 4 month and 6 month
measure: Micro- and macro-albuminuria
timeFrame: Change in serum albumin measured at baseline and 6 month
measure: Fasting blood glucose
timeFrame: Change in fasting blood glucose measured at baseline and 6 month
measure: Fasting lipid profile
timeFrame: Change in serum lipid profile measured at baseline and 6 month
measure: Serum sodium
timeFrame: Change in serum sodium measured at baseline and 6 month
measure: Serum potassium
timeFrame: Change in serum potassium measured at baseline and 6 month
measure: Serum urea
timeFrame: Change in serum urea measured at baseline and 6 month
measure: Serum creatinine
timeFrame: Change in serum creatinine measured at baseline and 6 month
measure: eGFR
timeFrame: Change in eGFR measured at baseline and 6 month
measure: Adverse events causing trial withdrawal
timeFrame: adverse events causing withdrawal at 2 month, 4 month and 6 month
measure: renin and aldosterone
timeFrame: Change in plasme renin and/or aldosterone measured at baseline and 6 month
Other outcomes:
Locations:
city: Guntur
country: India
facility: Lalitha Super Specialities Hospital
state: Andhra Pradesh
city: Visakhapatnam
country: India
facility: Apollo Hospitals
state: Andhra Pradesh
city: Dibrugarh
country: India
facility: Assam Medical College
state: Assam
city: Guwahati
country: India
facility: Apollo-Excelcare Hospital
state: Assam
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
state: Delhi
city: New Delhi
country: India
facility: Indraprastha Apollo Hospitals
state: Delhi
city: Ahmedabad
country: India
facility: Apollo Hospitals
state: Gujarat
city: Vadodara
country: India
facility: Aman Hospital & Research Center
state: Gujarat
city: Ahmedabad
country: India
facility: Rudraksha Hospital
state: Gujrat
city: Bangalore
country: India
facility: Lifecare Hospital & Research Centre
state: Karnataka
city: Dharwad
country: India
facility: SDM College of Medical Sciences & Hospital
state: Karnataka
city: Mangalore
country: India
facility: Indiana Hospital & Heart Institute
state: Karnataka
city: Mysore
country: India
facility: JSS Hospital
state: Karnataka
city: Vijayapura
country: India
facility: BLDE, Shri B. M. Patil Medical College, Hospital & Research Centre
state: Karnataka
city: Ernakulam
country: India
facility: Lisie Hospital
state: Kerela
city: Palakkad
country: India
facility: Lakshmi Hospital
state: Kerela
city: Devran
country: India
facility: BKL Walawalkar Rural Medical College and Hospital
state: Maharashtra
city: Mumbai
country: India
facility: Bhatia Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Sengupta Hospital & Research Institute
state: Maharashtra
city: Nagpur
country: India
facility: Shalinitai Meghe Hospital and Research Center
state: Maharashtra
city: Shillong
country: India
facility: Nazareth Hospital
state: Meghalaya
city: Shillong
country: India
facility: North Eastern Indira Gandhi Regional Institute of Medical Sciences
state: Meghalaya
city: Bhubaneshwar
country: India
facility: Apollo Hospitals
state: Odisha
city: Bhatinda
country: India
facility: All India Institute of Medical Sciences
state: Punjab
city: Ludhiāna
country: India
facility: Dayanand Medical College and Hospital
state: Punjab
city: Patiala
country: India
facility: Sadbhavna Medical and Heart Institute
state: Punjab
city: Bikaner
country: India
facility: SP Medical College
state: Rajasthan
city: Jodhpur
country: India
facility: All India Institute of Medical Sciences
state: Rajasthan
city: Chennai
country: India
facility: Madras Medical College
state: Tamil Nadu
city: Chennai
country: India
facility: Sri Ramchandra Institute of Higher Education and Research
state: Tamil Nadu
city: Madurai
country: India
facility: Apollo Hospital
state: Tamil Nadu
city: Hyderabad
country: India
facility: Osmania General Hospital
state: Telangana
city: Hyderabad
country: India
facility: Apollo DRDO Hospitals
state: Telangana
city: Hyderabad
country: India
facility: Apollo Institute of Medical Sciences
state: Telangana
city: Hyderabad
country: India
facility: Mediciti Institute of Medical Sciences
state: Telangana
Study officials:
affiliation: Centre for Chronic Disease Control, New Delhi
name: Dorairaj Prabhakaran, DM Cardiology
role: PRINCIPAL_INVESTIGATOR
References: