Treatment Optimisation for Blood Pressure With Single-Pill Combinations in India
- Conditions
- Primary Hypertension
- Interventions
- Registration Number
- NCT05683301
- Lead Sponsor
- Centre for Chronic Disease Control, India
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1981
- Age 30-79 years AND
- Sitting clinic values* of SBP ≥140 mmHg and <160 mmHg on one antihypertensive agent OR
- Sitting clinic values* of SBP ≥150 mmHg and <180 mmHg on no antihypertensive treatment * Mean of the last 2 of 3 readings.
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Congestive heart failure (clinically defined).
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Patients with a history of intolerance to any of the study medications for example angioedema or dry cough with Angiotensin-converting enzyme inhibitors.
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Serum creatinine levels greater than 132.6µmol/l (1.5mg/dl)
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- History of coronary heart disease (i.e., chronic stable angina, myocardial infarction or acute coronary syndrome).
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History of a stroke or other cerebrovascular accident (i.e. transient ischaemic attack or reversible ischaemic neurological deficit).
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Severe hepatic impairment
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Treatment with agents causing torsades de pointes
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Lactation
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Contraindications to any of the investigational medicinal products as per the summaries product characteristics of drugs studied
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Known or suspected secondary hypertension.
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Any other concomitant illness, physical or mental impairment that could interfere with the effective conduct of the study.
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Pregnancy or those of child-bearing age who are not taking reliable contraception.
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History of Gout.
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Serum potassium < 3.5mmol/L at screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 Perindopril + Indapamide (Arm 1 compare to Arm 2 compare to Arm 3) - Treatment Period 1 (Enrollment - 2 months) - Single Pill Combination of Perindopril 4 mg and Indapamide 1.25 mg once daily, orally Treatment Period 2 (2 months - 6 months) - Single Pill Combination of Perindopril 8 mg and Indapamide 2.5 mg once daily, orally Arm 3 Amlodipine + Indapamide (Arm 1 compare to Arm 2 compare to Arm 3) - Treatment Period 1 (Enrollment - 2 months) - Single Pill Combination of Amlodipine 5 mg and Indapamide 1.5 mg sustained release once daily, orally Treatment Period 2 (2 months - 6 months) - Single Pill Combination of Amlodipine 10 mg and Indapamide 1.5 mg sustained release once daily, orally Arm 1 Amlodipine + Perindopril (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 Treatment Period 2 (2 months - 6 months) - Single Pill Combination of Amlodipine 10 mg and Perindopril 8 mg once daily, orally
- Primary Outcome Measures
Name Time Method 24-hour ambulatory systolic Blood Pressure Change in between baseline and 6 month Ambulatory Systolic Blood Pressure To determine which of three single pill combinations of two anti-hypertensive agents is most effective in reducing 24-hour ambulatory systolic BP (ASBP) in Indian patients with hypertension.
- Secondary Outcome Measures
Name Time Method Serum creatinine Change in serum creatinine measured at baseline and 6 month To determine the effect of three single pill combinations of two antihypertensive agents on serum creatinine
eGFR Change in eGFR measured at baseline and 6 month To determine the effect of three single pill combinations of two antihypertensive agents on eGFR
renin and aldosterone Change in plasme renin and/or aldosterone measured at baseline and 6 month To determine whether baseline plasma renin and/or aldosterone predicts any differential BP effects of the three single-pill combinations under investigation.
Serum potassium Change in serum potassium measured at baseline and 6 month To determine the effect of three single pill combinations of two antihypertensive agents on serum potassium
24-hour ambulatory diastolic blood pressure Change in between baseline and 6 month Ambulatory Diastolic Blood Pressure To determine which of three single pill combinations of two antihypertensive agents is most effective in reducing 24-hour ambulatory diastolic blood pressure at 6 months adjusted for baseline ADBP
Clinic Blood Pressure Comparison of Clinic blood pressure measured at baseline 2 month , 4 month and 6 month To determine which of three single pill combinations of two antihypertensive agents is most effective in reducing Clinic SBP and diastolic blood pressure (DBP) at two, four and six months adjusted for baseline values
Daytime and nighttime Blood Pressure Change in between baseline and 6 month ASBP and ADBP To determine which of three single pill combinations of two antihypertensive agents is most effective in reducing Daytime and nighttime blood pressure (BP) a t six months adjusted for baseline values
BP variability measured by ABPM and within-visit clinic BPs 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 To determine which of three single pill combinations of two antihypertensive agents is most effective in reducing 3.2.4. BP variability measured by ASBP and within-visit clinic BP
Micro- and macro-albuminuria Change in serum albumin measured at baseline and 6 month To determine the effect of three single pill combinations of two antihypertensive agents on Micro- and macro-albuminuria.
Proportion of patients who achieve BP control 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 To determine which of the three single pill combinations of two antihypertensive agents is most effective in increasing the proportion of patients who achieve BP control defined as BP: \<140/90 mmHg and \<130/80mmHg at any of their clinic visits and maintained at the 6-month clinic visit.
Proportion of patients classified as "responders" Clinic BP as measured at baseline, 2 month, 4 month and 6 month Proportion of patients classified as "responders" defined as those who had a reduction of SBP ≥20mmHg and DBP ≥10 mmHg at any of their clinic visits and maintained at the 6-month clinic visit.
Fasting blood glucose Change in fasting blood glucose measured at baseline and 6 month To determine the effect of three single pill combinations of two antihypertensive agents on Fasting blood glucose.
Serum sodium Change in serum sodium measured at baseline and 6 month To determine the effect of three single pill combinations of two antihypertensive agents on serum sodium
Serum urea Change in serum urea measured at baseline and 6 month To determine the effect of three single pill combinations of two antihypertensive agents on serum urea
Adverse events causing trial withdrawal adverse events causing withdrawal at 2 month, 4 month and 6 month To determine the effect of three single pill combinations of two antihypertensive agents on adverse events causing trial withdrawal
Fasting lipid profile Change in serum lipid profile measured at baseline and 6 month To determine the effect of three single pill combinations of two antihypertensive agents on fasting lipid profile.
Trial Locations
- Locations (31)
Apollo Hospitals
🇮🇳Bhubaneshwar, Odisha, India
Assam Medical College
🇮🇳Dibrugarh, Assam, India
Indraprastha Apollo Hospitals
🇮🇳New Delhi, Delhi, India
Aman Hospital & Research Center
🇮🇳Vadodara, Gujarat, India
Lifecare Hospital & Research Centre
🇮🇳Bangalore, Karnataka, India
Indiana Hospital & Heart Institute
🇮🇳Mangalore, Karnataka, India
BLDE, Shri B. M. Patil Medical College, Hospital & Research Centre
🇮🇳Vijayapura, Karnataka, India
BKL Walawalkar Rural Medical College and Hospital
🇮🇳Devran, Maharashtra, India
Bhatia Hospital
🇮🇳Mumbai, Maharashtra, India
Shalinitai Meghe Hospital and Research Center
🇮🇳Nagpur, Maharashtra, India
Nazareth Hospital
🇮🇳Shillong, Meghalaya, India
Sadbhavna Medical and Heart Institute
🇮🇳Patiala, Punjab, India
SP Medical College
🇮🇳Bikaner, Rajasthan, India
Apollo Hospital
🇮🇳Madurai, Tamil Nadu, India
Osmania General Hospital
🇮🇳Hyderabad, Telangana, India
Apollo DRDO Hospitals
🇮🇳Hyderabad, Telangana, India
Apollo Institute of Medical Sciences
🇮🇳Hyderabad, Telangana, India
Mediciti Institute of Medical Sciences
🇮🇳Hyderabad, Telangana, India
Lalitha Super Specialities Hospital
🇮🇳Guntur, Andhra Pradesh, India
Apollo-Excelcare Hospital
🇮🇳Guwahati, Assam, India
All India Institute of Medical Sciences
🇮🇳Jodhpur, Rajasthan, India
Rudraksha Hospital
🇮🇳Ahmedabad, Gujrat, India
SDM College of Medical Sciences & Hospital
🇮🇳Dharwad, Karnataka, India
JSS Hospital
🇮🇳Mysore, Karnataka, India
Lisie Hospital
🇮🇳Ernakulam, Kerela, India
Lakshmi Hospital
🇮🇳Palakkad, Kerela, India
Sengupta Hospital & Research Institute
🇮🇳Nagpur, Maharashtra, India
North Eastern Indira Gandhi Regional Institute of Medical Sciences
🇮🇳Shillong, Meghalaya, India
Dayanand Medical College and Hospital
🇮🇳Ludhiāna, Punjab, India
Madras Medical College
🇮🇳Chennai, Tamil Nadu, India
Sri Ramchandra Institute of Higher Education and Research
🇮🇳Chennai, Tamil Nadu, India