Back to resultsTreatment Optimisation for Blood Pressure With Single-Pill Combinations in India (TOPSPIN)
Primary Purpose
Primary Hypertension
Status
Recruiting
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Amlodipine + Perindopril
Perindopril + Indapamide
Amlodipine + Indapamide
Sponsored by
About this trial
This is an interventional other trial for Primary Hypertension
Eligibility Criteria
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. -
Sites / Locations
- Lalitha Super Specialities HospitalRecruiting
- Apollo-Excelcare HospitalRecruiting
- All India Institute of Medical SciencesRecruiting
- Rudraksha HospitalRecruiting
- SDM College of Medical Sciences & HospitalRecruiting
- JSS HospitalRecruiting
- Lisie HospitalRecruiting
- Lakshmi HospitalRecruiting
- Sengupta Hospital & Research InstituteRecruiting
- North Eastern Indira Gandhi Regional Institute of Medical SciencesRecruiting
- Dayanand Medical College and HospitalRecruiting
- All India Institute of Medical SciencesRecruiting
- Madras Medical CollegeRecruiting
- Sri Ramchandra Institute of Higher Education and ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Arm 1
Arm 2
Arm 3
Arm Description
(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 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 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
Outcomes
Primary Outcome Measures
24-hour 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 Outcome Measures
24-hour 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
Clinic Blood Pressure
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
Daytime and nighttime Blood Pressure
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
BP variability measured by ABPM and within-visit clinic BPs
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
Proportion of patients who achieve BP control
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.
Proportion of patients classified as "responders"
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.
Micro- and macro-albuminuria
To determine the effect of three single pill combinations of two antihypertensive agents on Micro- and macro-albuminuria.
Fasting blood glucose
To determine the effect of three single pill combinations of two antihypertensive agents on Fasting blood glucose.
Fasting lipid profile
To determine the effect of three single pill combinations of two antihypertensive agents on fasting lipid profile.
Serum sodium
To determine the effect of three single pill combinations of two antihypertensive agents on serum sodium
Serum potassium
To determine the effect of three single pill combinations of two antihypertensive agents on serum potassium
Serum urea
To determine the effect of three single pill combinations of two antihypertensive agents on serum urea
Serum creatinine
To determine the effect of three single pill combinations of two antihypertensive agents on serum creatinine
eGFR
To determine the effect of three single pill combinations of two antihypertensive agents on eGFR
Adverse events causing trial withdrawal
To determine the effect of three single pill combinations of two antihypertensive agents on adverse events causing trial withdrawal
renin and aldosterone
To determine whether baseline plasma renin and/or aldosterone predicts any differential BP effects of the three single-pill combinations under investigation.
Full Information
NCT ID
NCT05683301
First Posted
December 10, 2022
Last Updated
January 12, 2023
Sponsor
Centre for Chronic Disease Control, India
Collaborators
Imperial College London, All India Institute of Medical Sciences, New Delhi
1. Study Identification
Unique Protocol Identification Number
NCT05683301
Brief Title
Treatment Optimisation for Blood Pressure With Single-Pill Combinations in India
Acronym
TOPSPIN
Official Title
Treatment Optimisation for Blood Pressure With Single-Pill Combinations in India
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Chronic Disease Control, India
Collaborators
Imperial College London, All India Institute of Medical Sciences, New Delhi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 15 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypertension
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1968 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
(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 Title
Arm 2
Arm Type
Experimental
Arm Description
(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 Title
Arm 3
Arm Type
Experimental
Arm Description
(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
Intervention Type
Drug
Intervention Name(s)
Amlodipine + Perindopril
Intervention Description
Single pill combination of dual antihypertensive agent
Intervention Type
Drug
Intervention Name(s)
Perindopril + Indapamide
Intervention Description
Single pill combination of dual antihypertensive agent
Intervention Type
Drug
Intervention Name(s)
Amlodipine + Indapamide
Intervention Description
Single pill combination of dual antihypertensive agent
Primary Outcome Measure Information:
Title
24-hour ambulatory systolic Blood Pressure
Description
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.
Time Frame
Change in between baseline and 6 month Ambulatory Systolic Blood Pressure
Secondary Outcome Measure Information:
Title
24-hour ambulatory diastolic blood pressure
Description
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
Time Frame
Change in between baseline and 6 month Ambulatory Diastolic Blood Pressure
Title
Clinic Blood Pressure
Description
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
Time Frame
Comparison of Clinic blood pressure measured at baseline 2 month , 4 month and 6 month
Title
Daytime and nighttime Blood Pressure
Description
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
Time Frame
Change in between baseline and 6 month ASBP and ADBP
Title
BP variability measured by ABPM and within-visit clinic BPs
Description
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
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
Title
Proportion of patients who achieve BP control
Description
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.
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
Title
Proportion of patients classified as "responders"
Description
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.
Time Frame
Clinic BP as measured at baseline, 2 month, 4 month and 6 month
Title
Micro- and macro-albuminuria
Description
To determine the effect of three single pill combinations of two antihypertensive agents on Micro- and macro-albuminuria.
Time Frame
Change in serum albumin measured at baseline and 6 month
Title
Fasting blood glucose
Description
To determine the effect of three single pill combinations of two antihypertensive agents on Fasting blood glucose.
Time Frame
Change in fasting blood glucose measured at baseline and 6 month
Title
Fasting lipid profile
Description
To determine the effect of three single pill combinations of two antihypertensive agents on fasting lipid profile.
Time Frame
Change in serum lipid profile measured at baseline and 6 month
Title
Serum sodium
Description
To determine the effect of three single pill combinations of two antihypertensive agents on serum sodium
Time Frame
Change in serum sodium measured at baseline and 6 month
Title
Serum potassium
Description
To determine the effect of three single pill combinations of two antihypertensive agents on serum potassium
Time Frame
Change in serum potassium measured at baseline and 6 month
Title
Serum urea
Description
To determine the effect of three single pill combinations of two antihypertensive agents on serum urea
Time Frame
Change in serum urea measured at baseline and 6 month
Title
Serum creatinine
Description
To determine the effect of three single pill combinations of two antihypertensive agents on serum creatinine
Time Frame
Change in serum creatinine measured at baseline and 6 month
Title
eGFR
Description
To determine the effect of three single pill combinations of two antihypertensive agents on eGFR
Time Frame
Change in eGFR measured at baseline and 6 month
Title
Adverse events causing trial withdrawal
Description
To determine the effect of three single pill combinations of two antihypertensive agents on adverse events causing trial withdrawal
Time Frame
adverse events causing withdrawal at 2 month, 4 month and 6 month
Title
renin and aldosterone
Description
To determine whether baseline plasma renin and/or aldosterone predicts any differential BP effects of the three single-pill combinations under investigation.
Time Frame
Change in plasme renin and/or aldosterone measured at baseline and 6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kavita Singh, PhD
Phone
011-41618456
Ext
4812
Email
kavita@ccdcindia.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorairaj Prabhakaran, DM Cardiology
Organizational Affiliation
Centre for Chronic Disease Control, New Delhi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lalitha Super Specialities Hospital
City
Guntur
State/Province
Andhra Pradesh
ZIP/Postal Code
522001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
P V Raghava Sarma, DM Cardiology
Facility Name
Apollo-Excelcare Hospital
City
Guwahati
State/Province
Assam
ZIP/Postal Code
781033
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neil Bardoloi, DM Cardiology
Facility Name
All India Institute of Medical Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ambuj Roy, DM Cardiology
Facility Name
Rudraksha Hospital
City
Ahmedabad
State/Province
Gujrat
ZIP/Postal Code
382425
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vinod K Abichandani, MD Medicine
Facility Name
SDM College of Medical Sciences & Hospital
City
Dharwad
State/Province
Karnataka
ZIP/Postal Code
580009
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kiran Aithal, MD General Medicine
Facility Name
JSS Hospital
City
Mysore
State/Province
Karnataka
ZIP/Postal Code
570004
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunil Kumar S, DM Cardiology
Facility Name
Lisie Hospital
City
Ernakulam
State/Province
Kerela
ZIP/Postal Code
682018
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jabir Abdullakutty, DM Cardiology
Facility Name
Lakshmi Hospital
City
Palakkad
State/Province
Kerela
ZIP/Postal Code
678013
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jayagopal P B, DM Cardiology
Facility Name
Sengupta Hospital & Research Institute
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440033
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shantanu Sengupta, MD Medicine
Facility Name
North Eastern Indira Gandhi Regional Institute of Medical Sciences
City
Shillong
State/Province
Meghalaya
ZIP/Postal Code
793018
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amit Malviya, DM Cardiology
Facility Name
Dayanand Medical College and Hospital
City
Ludhiāna
State/Province
Punjab
ZIP/Postal Code
141001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bishav Mohan, DM Cardiology
Facility Name
All India Institute of Medical Sciences
City
Jodhpur
State/Province
Rajasthan
ZIP/Postal Code
342005
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Surender Deora, DM Cardiology
Facility Name
Madras Medical College
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600003
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
G Justin Paul, DM Cardiology
Facility Name
Sri Ramchandra Institute of Higher Education and Research
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600116
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nagendra Boopathy, DM Cardiology
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment Optimisation for Blood Pressure With Single-Pill Combinations in India
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