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Comparative study of three Calcium channel blockers in Hypertension by 24 hour BP monitoring

Comparison of the Efficacy of 24 Hour BP Control of Azelnidipine, Amlodipine and Cilnidipine in Mild to Moderate Essential Hypertension – a Prospective Multi-centric Parallel Arm Real-world Study (AMCILAZ-EH Study) - AMCILAZ-EH Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/072999
Enrollment
144
Registered
2024-08-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I10- Essential (primary) hypertension

Interventions

Intervention1: Amlodipine: Amlodipine is an approved medication for essential hypertension and is available widely Dose - start with 5 mg once a day and may increase to 10 mg after four weeks at the

Sponsors

Associates for Cardiology Education and Research in Tamilnadu(ACERT)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Known cases of Essential hypertension ie. = 140/90 mm Hg as Office based recording that are naïve to beta-blocker, and CCB OR Known cases of Essential hypertension ie. = 140/90 mm Hg as Office based recording along with either T2DM, LVD and/or CKD that are naïve to beta-blocker, and CCB

Exclusion criteria

Exclusion criteria: known allergy to any of the Calcium channel blockers, history of active thyroid disease, CKD stage 3 or more, eGFR less than 30 ml/min/sq.m, Office BP more than 180/110 mm Hg, Secondary hypertension, type 1 diabetes mellitus, active liver disease, pregnant women, women planning pregnancy or lactating mother, person working in night shift, more than moderate valvular heart disease, pericardial disease, irregular rhythm like atrial fibrillation, unstable heart disease or heart failure.

Design outcomes

Primary

MeasureTime frame
Change in Awake, 24 hour and Asleep Blood Pressure (SBP/DBP) between baseline and 8 weeks for the three arms using ABPM Change in office based Blood Pressure (SBP/DBP) between baseline and 4th, 8th week and 12th week for all the three arms Timepoint: 8 weeks for the three arms using ABPM Change in office based Blood Pressure (SBP/DBP) between baseline and 4th, 8th week and 12th week for all the three arms

Secondary

MeasureTime frame
change in dipping pattern between groupsTimepoint: 8 weeks;Changes in left ventricular (LV) mass index, LV Hypertrophy, LV global longitudinal strain, left atrial strainTimepoint: 12 weeks;changes in microalbuminuria/ albumin creatinine ratio between the three groupsTimepoint: 12 weeks;Proportions of patients achieving awake BP control of 135/85 mm Hg by ambulatory BPTimepoint: 8 weeks;proportions of patients achieving treatment induced adverse effectsTimepoint: 12 weeks;study the change in heart rate by ambulatory BP in the three groupsTimepoint: 8 weeks

Countries

India

Contacts

Public ContactDPrabhakar

Ashwin Clinic

prabhud19@gmail.com9884012727

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026