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Topspin Clinical Trial

Topspin Clinical Trial

Treatment Optimisation for blood Pressure with Single-Pill combinations in India

Collaborated with CCDC – CLINICAL TRIAL ON antihypertensive drugs- TOPSPIN trial completed

Funded By

Centre for Chronic Disease Control

IEC Approval

IEC Approval

Institutional Ethics Committee approval for Treatment Optimization for Blood pressure with Single-pil combinations in India

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Publications

Research findings and scientific publications from our landmark study

Comparison of dual therapies for hypertension treatment in India: a randomized clinical trial

Background

  1. Hypertension is leading contributor to the death and disability worldwide
    1. Prevalence among urban residents in India: 34%
    2. Prevalence among rural residents in India: 28%
    3. Hypertension control rates- 11% (rural) and 34% (urban); which is considerably low.
  2. Patients with hypertension need ≥2 drugs to reach BP targets.
    1. Latest Hypertension guidelines recommend combining dose of 2 or more drugs (SPC) in order to achieve the target BP control.
  3. However, no evidence among South Asian on choosing a SPC.

Study objectives

Primary objective

  1. To compare the efficacy of three single pill combinations (SPCs) of two anti-hypertensive agents on 24-hour ambulatory systolic blood pressure (ASBP) among individuals with hypertension in India.

Secondary objectives

  1. To determine which of the three SPCs most effective in reducing
    1. 24- hour ambulatory diastolic BP (ADBP)
    2. Clinic BP
    3. Daytime and night time Ambulatory BP
    4. BP variability measured by ASBP and within- visit clinic BP
    5. Proportion of patients who achieve BP control
    6. Proportion of patients classified as responders
    7. Micro and macro- albuminuria
    8. Fasting blood glucose
    9. Fasting lipid profile
    10. Serum sodium, potassium, urea, creatinine and eGFR
    11. Adverse events causing trial withdrawal

Study Design

Randomised, single blind, Parallel group, multi-centre , three-arm superiority trial.

The trail will be conducted at approximately 15 investigational sites in India.

Participants will be randomised to one of the three treatments

Treatment regimens

  1. Treatment A : Amlodipine + Perindopril
  2. Treatment B: Perindopril + Indapamide
  3. Treatment C: Amlodipine + Indapamide

Ethical Considerations

  1. Insurance and Indemnity: The sponsors, Imperial College London, UK, has purchased insurance coverage for this study in accordance with the laws and regulations of the country.
  2. Trial registration: The study will be registered on Clinical Trial Registry India and Clinicaltrials.gov in accordance with requirements of the International Committee of Medical Journal Editors (ICMJE) regulations.
  3. Informed consent: The Investigator should fully inform the patient of all the important aspects of the clinical trial including approval of the trial by the ethics committee. Prior to the participation of the patient in the study, the informed consent form should be signed and personally dated by the patient and by the site investigator/delegate.
  4. Subject Confidentiality: Study data sent to the Electronic Clinical Data Management System at the Research Coordinating Centre at CCDC will be securely stored

Study Organization

  1. Study Sponsor: Imperial college, London, United Kingdom
  2. Study collaborators: Center for Chronic Disease Control, New Delhi. All India Institute of Medical sciences.
  3. Trial coordination: Centre for Chronic Disease Control
  4. Drug supply: Servier Pharmaceutical, India
  5. Drug labelling, packaging and distribution: Bilcare Pvt Ltd.

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