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comparison of three combinations of two blood pressure lowering drugs on central arterial stiffness and pressure in patients with hypertension

Comparison of the Effects of Three Single Pill Combinations of two drugs Therapies on Aortic Stiffness and Central Arterial Pressure in Patients with hypertension

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/11/047463
Enrollment
210
Registered
2022-11-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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: Single Pill Combination of Amlodipine and Perindopril: 1. Amlodipine 5mg and Perindopril 4 mg once daily. 2. Amlodipine 10mg and Perindopril 8 mg once daily [If target control of blood

Sponsors

Imperial College of London
Lead Sponsor
Shri Dharmasthala Manjunatheshwara University
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with Sitting clinic values of Systolic blood pressure between 140 mmHg and 160 mmHg on one antihypertensive agent OR 2. Patient with Sitting clinic values of Systolic Blood Pressure between 150 mmHg and 180 mmHg on no antihypertensive treatment

Exclusion criteria

Exclusion criteria: 1. Congestive heart failure (clinically defined). 2. Patients with a history of intolerance to any of the study medications for example angioedema or dry cough with ACE-inhibitors. 3. Serum creatinine levels greater than 132.6 µmol/l (1.5mg/dl) 4. History of coronary heart disease (i.e chronic stable angina, myocardial infarction or acute coronary syndrome). 5. History of a stroke or other cerebrovascular accident (i.e. transient ischaemic attack or reversible ischaemic neurological deficit). 6. Severe hepatic impairment 7. Treatment with agents causing torsades de pointes 8. Lactation 9. Contraindications to any of the investigational medicinal products as per the SmPc of drugs studied 10. Known or suspected secondary hypertension. 11. Any other concomitant illness, physical or mental impairment that could interfere with the effective conduct of the study. 12. Pregnancy or those of child-bearing age who are not taking reliable contraception. 13. History of Gout. 14. Serum potassium less than 3.5mmol/L at screening.

Design outcomes

Secondary

MeasureTime frame
Change in biochemical markers of oxidative stress and MMP-2 & 9Timepoint: Changes from baseline to 2,4 and 6 months;Changes in central arterial blood pressure (carotid artery)Timepoint: Changes in central arterial blood pressure from baseline to 2,4 and 6 months;Changes in local carotid arterial stiffnessTimepoint: Changes in local carotid stiffness from baseline to 2,4 and 6 months

Primary

MeasureTime frame
Changes in aortic stiffness by measuring carotid to femoral pulse wave velocity (cf-PWV)Timepoint: At baseline, 2 month, 4 month and 6 month

Countries

India

Contacts

Public ContactSatish G Patil

SDM College of Medical Sciences and Hospital

satish.patil@sdmuniversity.edu.in9986789583

Outcome results

None listed

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