NCT05683301CompletedPhase 4
Treatment Optimisation for Blood Pressure With Single-Pill Combinations in India
Source: ClinicalTrials.gov · Last updated 8 Oct 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 1981 (actual)
- First submitted
- 10 Dec 2022
- Start date
- 30 Aug 2022
- Primary completion date
- 30 Aug 2024
- Lead sponsor
- Centre for Chronic Disease Control, India
- Diseases
- High blood pressure
- NCT number
- NCT05683301
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 1981
- From 30 Aug 2022 to the primary completion date, 30 Aug 2024
- 35 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with agents causing torsades de pointes
- Contraindications to any of the investigational medicinal products as per the summaries product characteristics of drugs studied
- Any other concomitant illness, physical or mental impairment that could interfere with the effective conduct of the study.
Other illness
- Congestive heart failure (clinically defined).
- Patients with a history of intolerance to any of the study medications for example angioedema or dry cough with Angiotensin-converting enzyme inhibitors.
- 4\. History of coronary heart disease (i.e., chronic stable angina, myocardial infarction or acute coronary syndrome).
- History of a stroke or other cerebrovascular accident (i.e. transient ischaemic attack or reversible ischaemic neurological deficit).
- Severe hepatic impairment
- Known or suspected secondary hypertension.
- History of Gout.
Lab values
- Serum creatinine levels greater than 132.6µmol/l (1.5mg/dl)
- Serum potassium \< 3.5mmol/L at screening.
- \-
Age
- Pregnancy or those of child-bearing age who are not taking reliable contraception.
Other
- Lactation
Who the study is looking for
- 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.
Age in the registry: 30 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (35)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Apollo Hospitals Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| Rudraksha Hospital Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| Lifecare Hospital & Research Centre Coordinator of this site? Confirm its status | Bangalore | India | Unknown status |
| All India Institute of Medical Sciences Coordinator of this site? Confirm its status | Bathinda | India | Unknown status |
| Apollo Hospitals Coordinator of this site? Confirm its status | Bhubaneswar | India | Unknown status |
| SP Medical College Coordinator of this site? Confirm its status | Bikaner | India | Unknown status |
| Madras Medical College Coordinator of this site? Confirm its status | Chennai | India | Unknown status |
| Sri Ramchandra Institute of Higher Education and Research Coordinator of this site? Confirm its status | Chennai | India | Unknown status |
| BKL Walawalkar Rural Medical College and Hospital Coordinator of this site? Confirm its status | Devran | India | Unknown status |
| SDM College of Medical Sciences & Hospital Coordinator of this site? Confirm its status | Dharwad | India | Unknown status |
| Assam Medical College Coordinator of this site? Confirm its status | Dibrugarh | India | Unknown status |
| Lisie Hospital Coordinator of this site? Confirm its status | Ernākulam | India | Unknown status |
| Lalitha Super Specialities Hospital Coordinator of this site? Confirm its status | Guntur | India | Unknown status |
| Apollo-Excelcare Hospital Coordinator of this site? Confirm its status | Guwahati | India | Unknown status |
| Apollo DRDO Hospitals Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| Osmania General Hospital Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| Apollo Institute of Medical Sciences Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| Mediciti Institute of Medical Sciences Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| All India Institute of Medical Sciences Coordinator of this site? Confirm its status | Jodhpur | India | Unknown status |
| Dayanand Medical College and Hospital Coordinator of this site? Confirm its status | Ludhiana | India | Unknown status |
| Apollo Hospital Coordinator of this site? Confirm its status | Madurai | India | Unknown status |
| Indiana Hospital & Heart Institute Coordinator of this site? Confirm its status | Mangalore | India | Unknown status |
| Bhatia Hospital Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| JSS Hospital Coordinator of this site? Confirm its status | Mysore | India | Unknown status |
| Sengupta Hospital & Research Institute Coordinator of this site? Confirm its status | Nagpur | India | Unknown status |
| Shalinitai Meghe Hospital and Research Center Coordinator of this site? Confirm its status | Nagpur | India | Unknown status |
| All India Institute of Medical Sciences Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Indraprastha Apollo Hospitals Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Lakshmi Hospital Coordinator of this site? Confirm its status | Palakkad | India | Unknown status |
| Sadbhavna Medical and Heart Institute Coordinator of this site? Confirm its status | Patiāla | India | Unknown status |
| North Eastern Indira Gandhi Regional Institute of Medical Sciences Coordinator of this site? Confirm its status | Shillong | India | Unknown status |
| Nazareth Hospital Coordinator of this site? Confirm its status | Shillong | India | Unknown status |
| Aman Hospital & Research Center Coordinator of this site? Confirm its status | Vadodara | India | Unknown status |
| BLDE, Shri B. M. Patil Medical College, Hospital & Research Centre Coordinator of this site? Confirm its status | Vijayapura | India | Unknown status |
| Apollo Hospitals Coordinator of this site? Confirm its status | Visakhapatnam | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.