Primary HypertensionPhase 4TOPSPINNCT05683301

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

A Phase 4 study testing Amlodipine + Perindopril, Perindopril + Indapamide and Amlodipine + Indapamide in people with Primary Hypertension, run by Centre for Chronic Disease Control, India at 35 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 30 to 79 years
Conditions the study is for: Primary Hypertension
What is being tested?: Amlodipine + Perindopril, Perindopril + Indapamide and Amlodipine + Indapamide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,981 participants
Where: 35 sitesIndia
Study dates: 30 Aug 2022to 22 Sep 2024
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 15Show fewer

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.
-

Trial locations and contacts

35 sites in 1 country.

City, postcode or hospital

35 sites in 1 country

India35 sites

Rudraksha Hospital
Ahmedabad, Gujarat, 382425
Apollo Hospitals
Ahmedabad, Gujarat, 382428
Lifecare Hospital & Research Centre
Bangalore, Karnataka, 560092
All India Institute of Medical Sciences
Bathinda, Punjab, 151001
Apollo Hospitals
Bhubaneswar, Odisha, 751005
SP Medical College
Bikaner, Rajasthan, 334001
Madras Medical College
Chennai, Tamil Nadu, 600003
Sri Ramchandra Institute of Higher Education and Research
Chennai, Tamil Nadu, 600116
BKL Walawalkar Rural Medical College and Hospital
Devran, Maharashtra, 415606
SDM College of Medical Sciences & Hospital
Dharwad, Karnataka, 580009
Assam Medical College
Dibrugarh, Assam, 786002
Lisie Hospital
Ernākulam, Kerala, 682018
Lalitha Super Specialities Hospital
Guntur, Andhra Pradesh, 522001
Apollo-Excelcare Hospital
Guwahati, Assam, 781033
Osmania General Hospital
Hyderabad, Telangana, 500007
Apollo DRDO Hospitals
Hyderabad, Telangana, 500058
Apollo Institute of Medical Sciences
Hyderabad, Telangana, 500090
Mediciti Institute of Medical Sciences
Hyderabad, Telangana, 501401
All India Institute of Medical Sciences
Jodhpur, Rajasthan, 342005
Dayanand Medical College and Hospital
Ludhiana, Punjab, 141001
Apollo Hospital
Madurai, Tamil Nadu, 625020
Indiana Hospital & Heart Institute
Mangalore, Karnataka, 575002
Bhatia Hospital
Mumbai, Maharashtra, 400007
JSS Hospital
Mysore, Karnataka, 570004
Sengupta Hospital & Research Institute
Nagpur, Maharashtra, 440033
Shalinitai Meghe Hospital and Research Center
Nagpur, Maharashtra, 441110
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
Indraprastha Apollo Hospitals
New Delhi, National Capital Territory of Delhi, 110076
Lakshmi Hospital
Palakkad, Kerala, 678013
Sadbhavna Medical and Heart Institute
Patiāla, Punjab, 147001
Nazareth Hospital
Shillong, Meghālaya, 793003
North Eastern Indira Gandhi Regional Institute of Medical Sciences
Shillong, Meghālaya, 793018
Aman Hospital & Research Center
Vadodara, Gujarat, 390021
BLDE, Shri B. M. Patil Medical College, Hospital & Research Centre
Vijayapura, Karnataka, 586103
Apollo Hospitals
Visakhapatnam, Andhra Pradesh, 530002

Other trials in India

About this study

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

Read the 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.

Conditions: Primary Hypertension
Being tested: Amlodipine + Perindopril, Perindopril + Indapamide, Amlodipine + Indapamide
Medical subject headings: Essential Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Amlodipine + PerindoprilDrug
Single pill combination of dual antihypertensive agent
Perindopril + IndapamideDrug
Single pill combination of dual antihypertensive agent
Amlodipine + IndapamideDrug
Single pill combination of dual antihypertensive agent

Study groups in NCT05683301
Study group	Role	What they receive
Arm 1	Experimental	(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 Receives: Drug: Amlodipine + Perindopril
Arm 2	Experimental	(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 Receives: Drug: Perindopril + Indapamide
Arm 3	Experimental	(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 Receives: Drug: Amlodipine + Indapamide

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Change in between baseline and 6 month Ambulatory Systolic Blood Pressure

Secondary outcomes (16)

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
Measured: Change in between baseline and 6 month Ambulatory Diastolic Blood Pressure
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
Measured: Comparison of Clinic blood pressure measured at baseline 2 month , 4 month and 6 month
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
Measured: Change in between baseline and 6 month ASBP and ADBP
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
Measured: 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
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.
Measured: 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
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.
Measured: Clinic BP as measured at baseline, 2 month, 4 month and 6 month
Micro- and macro-albuminuria
To determine the effect of three single pill combinations of two antihypertensive agents on Micro- and macro-albuminuria.
Measured: Change in serum albumin measured at baseline and 6 month
Fasting blood glucose
To determine the effect of three single pill combinations of two antihypertensive agents on Fasting blood glucose.
Measured: Change in fasting blood glucose measured at baseline and 6 month
Fasting lipid profile
To determine the effect of three single pill combinations of two antihypertensive agents on fasting lipid profile.
Measured: Change in serum lipid profile measured at baseline and 6 month
Serum sodium
To determine the effect of three single pill combinations of two antihypertensive agents on serum sodium
Measured: Change in serum sodium measured at baseline and 6 month
Serum potassium
To determine the effect of three single pill combinations of two antihypertensive agents on serum potassium
Measured: Change in serum potassium measured at baseline and 6 month
Serum urea
To determine the effect of three single pill combinations of two antihypertensive agents on serum urea
Measured: Change in serum urea measured at baseline and 6 month
Serum creatinine
To determine the effect of three single pill combinations of two antihypertensive agents on serum creatinine
Measured: Change in serum creatinine measured at baseline and 6 month
eGFR
To determine the effect of three single pill combinations of two antihypertensive agents on eGFR
Measured: Change in eGFR measured at baseline and 6 month
Adverse events causing trial withdrawal
To determine the effect of three single pill combinations of two antihypertensive agents on adverse events causing trial withdrawal
Measured: adverse events causing withdrawal at 2 month, 4 month and 6 month
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.
Measured: Change in plasme renin and/or aldosterone measured at baseline and 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Aug 202222 Sep 2024

First posted13 Jan 2023
Study start30 Aug 2022
Primary completion30 Aug 2024
Study completion22 Sep 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Primary HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,981 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05683301
Sponsor's protocol ID: CCDC-2022-001
Acronym: TOPSPIN
Status last verified: Oct 2024
First submitted: 10 Dec 2022
Last updated: 8 Oct 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified data collected for the study will be shared with bonafide researchers with a valid research question. Request may be addressed to Prof. Prabhakaran - dprabhakaran@ccdcindia.org

Publications

Prabhakaran D, Roy A, Chandrasekaran AM, Kondal D, Mukherjee S, Kiru G, Singh K, Salwa H, Sobitharaj EC, Lobo AS, Mahajan G, Mohan B, Khanna A, Malviya A, Patil SG, Abichandani VK, Singh B, Gupta BK, Yellapantula B, Dandge S, Sengupta S, Kumar S, Bardoloi N, Senguttuvan NB, Sahay RK, Patil S, Deora S, Prahalad R, Sarvepalli VP, Gnanaraj JP, Khanna M, Mishra A, Aithal K, Chavda V, Cornelius VR; TOPSPIN Clinical Consortia; Poulter NR. Comparison of dual therapies for hypertension treatment in India: a randomized clinical trial. Nat Med. 2025 Sep;31(9):3169-3175. doi: 10.1038/s41591-025-03854-w. Epub 2025 Jul 25.
PubMed 40715816

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment Optimisation for Blood Pressure With Single-Pill Combinations in India
ClinicalTrials.gov ID: NCT05683301
Acronym / sponsor ID: TOPSPIN / CCDC-2022-001
Conditions: Primary Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,981 participants (actual)
Lead sponsor: Centre for Chronic Disease Control, IndiaUniversity, hospital or other
Collaborators: All India Institute of Medical Sciences, Imperial College London
Study start: 30 Aug 2022 (actual)
Primary completion: 30 Aug 2024 (actual)
Study completion: 22 Sep 2024 (actual)
First posted: 13 Jan 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Single Pill combinations (SPCs): 1) Amlodipine + Perindopril, 2) Perindopril + Indapamide, 3) Amlodipine + Indapamide

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Arm 1	Experimental	Drug: Amlodipine + Perindopril(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 2	Experimental	Drug: Perindopril + Indapamide(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 3	Experimental	Drug: Amlodipine + Indapamide(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

Who may qualify

Ages: 30 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (15 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Amlodipine + PerindoprilSingle pill combination of dual antihypertensive agent	Drug	Arm 1
Perindopril + IndapamideSingle pill combination of dual antihypertensive agent	Drug	Arm 2
Amlodipine + IndapamideSingle pill combination of dual antihypertensive agent	Drug	Arm 3

Primary outcome

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.

16 secondary outcomes

24-hour ambulatory diastolic blood pressure
Time frame: Change in between baseline and 6 month Ambulatory Diastolic Blood Pressure
Clinic Blood Pressure
Time frame: Comparison of Clinic blood pressure measured at baseline 2 month , 4 month and 6 month
Daytime and nighttime Blood Pressure
Time frame: Change in between baseline and 6 month ASBP and ADBP
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
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
Proportion of patients classified as "responders"
Time frame: Clinic BP as measured at baseline, 2 month, 4 month and 6 month
Micro- and macro-albuminuria
Time frame: Change in serum albumin measured at baseline and 6 month
Fasting blood glucose
Time frame: Change in fasting blood glucose measured at baseline and 6 month
Fasting lipid profile
Time frame: Change in serum lipid profile measured at baseline and 6 month
Serum sodium
Time frame: Change in serum sodium measured at baseline and 6 month
Serum potassium
Time frame: Change in serum potassium measured at baseline and 6 month
Serum urea
Time frame: Change in serum urea measured at baseline and 6 month
Serum creatinine
Time frame: Change in serum creatinine measured at baseline and 6 month
eGFR
Time frame: Change in eGFR measured at baseline and 6 month
Adverse events causing trial withdrawal
Time frame: adverse events causing withdrawal at 2 month, 4 month and 6 month
renin and aldosterone
Time frame: Change in plasme renin and/or aldosterone measured at baseline and 6 month

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
Derived from this study: PubMed 40715816Prabhakaran D, Roy A, Chandrasekaran AM, Kondal D, Mukherjee S, Kiru G, Singh K, Salwa H, Sobitharaj EC, Lobo AS, Mahajan G, Mohan B, Khanna A, Malviya A, Patil SG, Abichandani VK, Singh B, Gupta BK, Yellapantula B, Dandge S, Sengupta S, Kumar S, Bardoloi N, Senguttuvan NB, Sahay RK, Patil S, Deora S, Prahalad R, Sarvepalli VP, Gnanaraj JP, Khanna M, Mishra A, Aithal K, Chavda V, Cornelius VR; TOPSPIN Clinical Consortia; Poulter NR. Comparison of dual therapies for hypertension treatment in India: a randomized clinical trial. Nat Med. 2025 Sep;31(9):3169-3175. doi: 10.1038/s41591-025-03854-w. Epub 2025 Jul 25.
Individual participant dataSharing planned: Yes. De-identified data collected for the study will be shared with bonafide researchers with a valid research question. Request may be addressed to Prof. Prabhakaran - dprabhakaran@ccdcindia.org

Related trials for Primary Hypertension

Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
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RecruitingPhase 4
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Recruiting
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Active, not recruitingPhase 2
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dorairaj Prabhakaran, DM Cardiology principal investigator

Centre for Chronic Disease Control, New Delhi

35 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

24-hour ambulatory systolic Blood Pressure (time frame: Change in between baseline and 6 month Ambulatory Systolic Blood Pressure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05683301, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.