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Completed

NCT Number: NCT05683301

Treatment Optimisation for Blood Pressure With Single-Pill Combinations in India

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

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Key information

Conditions

Primary Hypertension Cardiovascular Diseases Essential Hypertension Hypertension Vascular Diseases

Age range

30 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Lalitha Super Specialities Hospital, Guntur, Andhra Pradesh, India

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Serum creatinine levels greater than 132.6µmol/l (1.5mg/dl)
  • 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
  • Treatment with agents causing torsades de pointes
  • Lactation
  • Contraindications to any of the investigational medicinal products as per the summaries product characteristics of drugs studied
  • Known or suspected secondary hypertension.
  • Any other concomitant illness, physical or mental impairment that could interfere with the effective conduct of the study.
  • Pregnancy or those of child-bearing age who are not taking reliable contraception.
  • History of Gout.
  • Serum potassium < 3.5mmol/L at screening.

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Treatment and study plan

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

  1. 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

  1. 24-hour ambulatory diastolic blood pressure

    Time frame: 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

  2. Clinic Blood Pressure

    Time frame: 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

  3. Daytime and nighttime Blood Pressure

    Time frame: 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

  4. 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

    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

  5. 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

    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.

  6. Proportion of patients classified as "responders"

    Time frame: 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.

  7. Micro- and macro-albuminuria

    Time frame: 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.

  8. Fasting blood glucose

    Time frame: 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.

  9. Fasting lipid profile

    Time frame: 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.

  10. Serum sodium

    Time frame: 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

  11. Serum potassium

    Time frame: 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

  12. Serum urea

    Time frame: 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

  13. Serum creatinine

    Time frame: 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

  14. eGFR

    Time frame: Change in eGFR measured at baseline and 6 month

    To determine the effect of three single pill combinations of two antihypertensive agents on eGFR

  15. Adverse events causing trial withdrawal

    Time frame: 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

  16. renin and aldosterone

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre for Chronic Disease Control, India

Other

Collaborators

  • All India Institute of Medical Sciences
  • Imperial College London

Registry information

Acronym: TOPSPIN

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 13, 2023
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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