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To find out the effectiveness and safety of a fixed-dose combination of perindopril 4mg & amlodipine 5 mg in reducing both the peripheral blood pressure (measured by a simple BP instrument) and aortic blood pressure (measured by a non-invasive instrument) in daily clinical practice

Evaluation of effect of Coversyl-AM on Peripheral and Central Aortic Blood Pressure In Daily Clinical Practice

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/07/001879
Enrollment
100
Registered
2011-07-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Hypertension

Interventions

Intervention1: Perindopril plus Amlodipine: Fixed-dose combination of Perindopril 4 mg & Amlodipine 5 mg Intervention2: Coversyl-AM (Fixed-dose combination of Perindopril 4 mg & Amlodipine 5 mg): All

Sponsors

Serdia Pharmaceuticals India Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ? Male and female patients between 40 years to 79 years of age ? Hypertensive patients who is either: a. Newly diagnosed, untreated moderate to severe hypertensive patients with SBP≥160 mm Hg and /or DBP≥100 mm Hg b. Patients inadequately controlled (SBP≥140 mm Hg and /or DBP ≥90 mm Hg) on monotherapy c. Patients inadequately controlled (SBP≥140 mm Hg and /or DBP ≥90 mm Hg) on any other combination therapy (given separately or as fixed-dose combination) ? Given written informed consent to participate in the study and agree for regular follow-up

Exclusion criteria

Exclusion criteria: ? Previous myocardial infarction ? Presently treated angina ? Cerebrovascular event within the previous 3 months ? Uncontrolled arrhythmia ? Heart failure ? Severe hepatic/ renal abnormalities ? Galactosemia ? Any contraindication to an ACE inhibitor and/or CCB ? Any clinically important hematological or biochemical abnormality ? Pregnancy/ Lactation

Design outcomes

Primary

MeasureTime frame
Reduction of peripheral & central aortic blood pressure from baseline to end of studyTimepoint: Month 0, Month 3, Month 6, Month 9 & Month 12

Secondary

MeasureTime frame
Safety profileTimepoint: Month 0, Month 3, Month 6, Month 9 & Month 12

Countries

India

Contacts

Public ContactDr Manjusha Rajarshi
ajaykumar.yadav@in.netgrs.com

Outcome results

None listed

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