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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
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

Full criteria on ClinicalTrials.gov

Sites (35)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Apollo Hospitals
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AhmedabadIndiaUnknown status
Rudraksha Hospital
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AhmedabadIndiaUnknown status
Lifecare Hospital & Research Centre
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BangaloreIndiaUnknown status
All India Institute of Medical Sciences
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BathindaIndiaUnknown status
Apollo Hospitals
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BhubaneswarIndiaUnknown status
SP Medical College
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BikanerIndiaUnknown status
Madras Medical College
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ChennaiIndiaUnknown status
Sri Ramchandra Institute of Higher Education and Research
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ChennaiIndiaUnknown status
BKL Walawalkar Rural Medical College and Hospital
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DevranIndiaUnknown status
SDM College of Medical Sciences & Hospital
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DharwadIndiaUnknown status
Assam Medical College
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DibrugarhIndiaUnknown status
Lisie Hospital
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ErnākulamIndiaUnknown status
Lalitha Super Specialities Hospital
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GunturIndiaUnknown status
Apollo-Excelcare Hospital
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GuwahatiIndiaUnknown status
Apollo DRDO Hospitals
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HyderabadIndiaUnknown status
Osmania General Hospital
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HyderabadIndiaUnknown status
Apollo Institute of Medical Sciences
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HyderabadIndiaUnknown status
Mediciti Institute of Medical Sciences
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HyderabadIndiaUnknown status
All India Institute of Medical Sciences
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JodhpurIndiaUnknown status
Dayanand Medical College and Hospital
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LudhianaIndiaUnknown status
Apollo Hospital
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MaduraiIndiaUnknown status
Indiana Hospital & Heart Institute
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MangaloreIndiaUnknown status
Bhatia Hospital
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MumbaiIndiaUnknown status
JSS Hospital
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MysoreIndiaUnknown status
Sengupta Hospital & Research Institute
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NagpurIndiaUnknown status
Shalinitai Meghe Hospital and Research Center
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NagpurIndiaUnknown status
All India Institute of Medical Sciences
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New DelhiIndiaUnknown status
Indraprastha Apollo Hospitals
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New DelhiIndiaUnknown status
Lakshmi Hospital
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PalakkadIndiaUnknown status
Sadbhavna Medical and Heart Institute
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PatiālaIndiaUnknown status
North Eastern Indira Gandhi Regional Institute of Medical Sciences
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ShillongIndiaUnknown status
Nazareth Hospital
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ShillongIndiaUnknown status
Aman Hospital & Research Center
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VadodaraIndiaUnknown status
BLDE, Shri B. M. Patil Medical College, Hospital & Research Centre
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VijayapuraIndiaUnknown status
Apollo Hospitals
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VisakhapatnamIndiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.