A Phase 4 interventional study of Amlodipine + Perindopril and Perindopril + Indapamide in Primary Hypertension, sponsored by Centre for Chronic Disease Control, India. Completed at 35 sites in India. Open to participants aged 30 Years to 79 Years. Per ClinicalTrials.gov, last updated 2024-10-08.
Sponsored by Centre for Chronic Disease Control, India · Phase 4, Interventional, and Other
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
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.
478 studies on the registry are indexed under Essential Hypertension; 74 are open to participants now.
This study's enrollment of 1,981 is above the median of 144 across 406 interventional studies indexed under Essential Hypertension.
Browse Essential Hypertension studies →Centre for Chronic Disease Control, India is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Serum potassium \< 3.5mmol/L at screening.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
(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
Drug: Amlodipine + Perindopril
(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
Drug: Perindopril + 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
Drug: Amlodipine + Indapamide
Drug pages: Amlodipine · Perindopril
Single pill combination of dual antihypertensive agent
Drug pages: Perindopril · Indapamide
Single pill combination of dual antihypertensive agent
Drug pages: Amlodipine · Indapamide
Single pill combination of dual antihypertensive agent
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.
Time frame: Change in between baseline and 6 month Ambulatory Systolic Blood Pressure
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
Time frame: 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
Time frame: 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
Time frame: 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
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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Change in plasme renin and/or aldosterone measured at baseline and 6 month
Plan to share: 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
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Time frame: 01-09-2025 till 30-09-2030
Access criteria: Only bonafide researchers with a valid research question shall be provided data. Interested researchers shall write to Prof. Prabhakaran (dprabhakaran@ccdcindia.org) with a concept note and necessary approvals as applicable.
No publications or documents are linked to this record.
Ran from Aug 2022 to primary completion in Aug 2024, 24 months.
Of 22 phase 4 interventional studies under Essential Hypertension, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 36. This study's 24 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Amlodipine · Perindopril · Indapamide
Centre for Chronic Disease Control, India