--- title: Treatment Optimisation for Blood Pressure With Single-Pill Combinations in India nct_id: NCT05683301 overall_status: COMPLETED phase: PHASE4 sponsor: Centre for Chronic Disease Control, India study_type: INTERVENTIONAL primary_condition: Primary Hypertension countries: India canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05683301.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05683301" ct_last_update_post_date: 2024-10-08 last_seen_at: "2026-05-12T07:15:55.885Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Treatment Optimisation for Blood Pressure With Single-Pill Combinations in India **NCT ID:** [NCT05683301](https://clinicaltrials.gov/study/NCT05683301) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE4 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 1981 - **Lead Sponsor:** Centre for Chronic Disease Control, India - **Collaborators:** All India Institute of Medical Sciences, Imperial College London - **Conditions:** Primary Hypertension - **Start Date:** 2022-08-30 - **Completion Date:** 2024-09-22 - **CT.gov Last Update:** 2024-10-08 ## 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 - **Minimum age:** 30 Years - **Maximum age:** 79 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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. \- ``` ## Arms - **Arm 1** (EXPERIMENTAL) — (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 - **Arm 2** (EXPERIMENTAL) — (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** (EXPERIMENTAL) — (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 ## Interventions - **Amlodipine + Perindopril** (DRUG) — Single pill combination of dual antihypertensive agent - **Perindopril + Indapamide** (DRUG) — Single pill combination of dual antihypertensive agent - **Amlodipine + Indapamide** (DRUG) — Single pill combination of dual antihypertensive agent ## Primary Outcomes - **24-hour ambulatory systolic Blood Pressure** _(time frame: 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 Outcomes - **24-hour ambulatory diastolic blood pressure** _(time frame: Change in between baseline and 6 month Ambulatory Diastolic Blood Pressure)_ - **Clinic Blood Pressure** _(time frame: Comparison of Clinic blood pressure measured at baseline 2 month , 4 month and 6 month)_ - **Daytime and nighttime Blood Pressure** _(time frame: Change in between baseline and 6 month ASBP and ADBP)_ - **BP variability measured by ABPM and within-visit clinic BPs** _(time frame: 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)_ - **Proportion of patients who achieve BP control** _(time frame: 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)_ - **Proportion of patients classified as "responders"** _(time frame: Clinic BP as measured at baseline, 2 month, 4 month and 6 month)_ - **Micro- and macro-albuminuria** _(time frame: Change in serum albumin measured at baseline and 6 month)_ - **Fasting blood glucose** _(time frame: Change in fasting blood glucose measured at baseline and 6 month)_ - **Fasting lipid profile** _(time frame: Change in serum lipid profile measured at baseline and 6 month)_ - **Serum sodium** _(time frame: Change in serum sodium measured at baseline and 6 month)_ - **Serum potassium** _(time frame: Change in serum potassium measured at baseline and 6 month)_ - **Serum urea** _(time frame: Change in serum urea measured at baseline and 6 month)_ - **Serum creatinine** _(time frame: Change in serum creatinine measured at baseline and 6 month)_ - **eGFR** _(time frame: Change in eGFR measured at baseline and 6 month)_ - **Adverse events causing trial withdrawal** _(time frame: adverse events causing withdrawal at 2 month, 4 month and 6 month)_ - **renin and aldosterone** _(time frame: Change in plasme renin and/or aldosterone measured at baseline and 6 month)_ ## Locations (35) - Lalitha Super Specialities Hospital, Guntur, Andhra Pradesh, India - Apollo Hospitals, Visakhapatnam, Andhra Pradesh, India - Assam Medical College, Dibrugarh, Assam, India - Apollo-Excelcare Hospital, Guwahati, Assam, India - Rudraksha Hospital, Ahmedabad, Gujarat, India - Apollo Hospitals, Ahmedabad, Gujarat, India - Aman Hospital & Research Center, Vadodara, Gujarat, India - Lifecare Hospital & Research Centre, Bangalore, Karnataka, India - SDM College of Medical Sciences & Hospital, Dharwad, Karnataka, India - Indiana Hospital & Heart Institute, Mangalore, Karnataka, India - JSS Hospital, Mysore, Karnataka, India - BLDE, Shri B. M. Patil Medical College, Hospital & Research Centre, Vijayapura, Karnataka, India - Lisie Hospital, Ernākulam, Kerala, India - Lakshmi Hospital, Palakkad, Kerala, India - BKL Walawalkar Rural Medical College and Hospital, Devran, Maharashtra, India - Bhatia Hospital, Mumbai, Maharashtra, India - Sengupta Hospital & Research Institute, Nagpur, Maharashtra, India - Shalinitai Meghe Hospital and Research Center, Nagpur, Maharashtra, India - Nazareth Hospital, Shillong, Meghālaya, India - North Eastern Indira Gandhi Regional Institute of Medical Sciences, Shillong, Meghālaya, India - All India Institute of Medical Sciences, New Delhi, National Capital Territory of Delhi, India - Indraprastha Apollo Hospitals, New Delhi, National Capital Territory of Delhi, India - Apollo Hospitals, Bhubaneswar, Odisha, India - All India Institute of Medical Sciences, Bathinda, Punjab, India - Dayanand Medical College and Hospital, Ludhiana, Punjab, India - Sadbhavna Medical and Heart Institute, Patiāla, Punjab, India - SP Medical College, Bikaner, Rajasthan, India - All India Institute of Medical Sciences, Jodhpur, Rajasthan, India - Madras Medical College, Chennai, Tamil Nadu, India - Sri Ramchandra Institute of Higher Education and Research, Chennai, Tamil Nadu, 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 ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `locations.sdm college of medical sciences & hospital|dharwad|karnataka|india` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.lalitha super specialities hospital|guntur|andhra pradesh|india` — added _(2026-05-12)_ - `locations.apollo hospitals|visakhapatnam|andhra pradesh|india` — added _(2026-05-12)_ - `locations.assam medical college|dibrugarh|assam|india` — added _(2026-05-12)_ - `locations.apollo-excelcare hospital|guwahati|assam|india` — added _(2026-05-12)_ - `locations.rudraksha hospital|ahmedabad|gujarat|india` — added _(2026-05-12)_ - `locations.apollo hospitals|ahmedabad|gujarat|india` — added _(2026-05-12)_ - `locations.aman hospital & research center|vadodara|gujarat|india` — added _(2026-05-12)_ - `locations.lifecare hospital & research centre|bangalore|karnataka|india` — added _(2026-05-12)_ - `locations.indiana hospital & heart institute|mangalore|karnataka|india` — added _(2026-05-12)_ - `locations.jss hospital|mysore|karnataka|india` — added _(2026-05-12)_ - `locations.blde, shri b. m. patil medical college, hospital & research centre|vijayapura|karnataka|india` — added _(2026-05-12)_ - `locations.lisie hospital|ernākulam|kerala|india` — added _(2026-05-12)_ - `locations.lakshmi hospital|palakkad|kerala|india` — added _(2026-05-12)_ - `locations.bkl walawalkar rural medical college and hospital|devran|maharashtra|india` — added _(2026-05-12)_ - `locations.bhatia hospital|mumbai|maharashtra|india` — added _(2026-05-12)_ - `locations.sengupta hospital & research institute|nagpur|maharashtra|india` — added _(2026-05-12)_ - `locations.shalinitai meghe hospital and research center|nagpur|maharashtra|india` — added _(2026-05-12)_ - `locations.nazareth hospital|shillong|meghālaya|india` — added _(2026-05-12)_ - `locations.north eastern indira gandhi regional institute of medical sciences|shillong|meghālaya|india` — added _(2026-05-12)_ - `locations.all india institute of medical sciences|new delhi|national capital territory of delhi|india` — added _(2026-05-12)_ - `locations.indraprastha apollo hospitals|new delhi|national capital territory of delhi|india` — added _(2026-05-12)_ - `locations.apollo hospitals|bhubaneswar|odisha|india` — added _(2026-05-12)_ - `locations.all india institute of medical sciences|bathinda|punjab|india` — added _(2026-05-12)_ - `locations.dayanand medical college and hospital|ludhiana|punjab|india` — added _(2026-05-12)_ - `locations.sadbhavna medical and heart institute|patiāla|punjab|india` — added _(2026-05-12)_ - `locations.sp medical college|bikaner|rajasthan|india` — added _(2026-05-12)_ - `locations.all india institute of medical sciences|jodhpur|rajasthan|india` — added _(2026-05-12)_ - `locations.madras medical college|chennai|tamil nadu|india` — added _(2026-05-12)_ - `locations.sri ramchandra institute of higher education and research|chennai|tamil nadu|india` — added _(2026-05-12)_ - `locations.apollo hospital|madurai|tamil nadu|india` — added _(2026-05-12)_ - `locations.osmania general hospital|hyderabad|telangana|india` — added _(2026-05-12)_ - `locations.apollo drdo hospitals|hyderabad|telangana|india` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT05683301.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT05683301* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*