Skip to content

A prospective, multicentre, open-label, single arm observational study of Concor® treatment in Asian patients with Essential Hypertension

A prospective, multicentre, open-label, single arm observational study of Concor® treatment in Asian patients with Essential Hypertension

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/002813
Enrollment
1000
Registered
2010-12-01
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

None listed

Interventions

Intervention1: BISOPROLOL: 5mg,10mg 6 MONTHS Control Intervention1: NIL: NIL

Sponsors

Merck Pte Ltd 3 International Business Park #02-01 Nordic European Centre Singapore 609927
Lead Sponsor
Merck Serono (Merck Ltd.) Mumbai. Shiv Sagar Estate &#039
Collaborator
A&#039
Collaborator
Dr. Annie Besant Road Worli, Mumbai 400 018.
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Patient aged 18 years old and above Patient diagnosed with essential hypertension Patient has been prescribed Concor® treatment but may or may not have commenced treatment in the last 2 weeks (from the date of signed informed consent) Patient has one of the following medical history prior to Concor® treatment ? Newly diagnosed with essential hypertension with repeated blood pressure measurements of > 140/90, or ? Current or preceding anti-hypertensive therapy does not result in adequate BP control, which requires either the addition of Concor® to the currently prescribed treatment or a change of treatment to Concor®, or ? Experiences adverse reaction with his current or preceding antihypertensive treatment Patient has a HR > 70 at baseline (before starting Concor treatment) Patient is regularly followed-up by/monitored by the investigator for essential hypertension Patient from whom a written informed consent has been obtained

Exclusion criteria

Exclusion criteria: completed >2 weeks of Concor® treatment acute heart failure or during episodes of heart failure decompensation requiring i.v. inotropic therapy cardiogenic shock second or third degree AV block (without a pacemaker) sick sinus syndrome sinoatrial block HR < 70 at baseline (before starting Concor treatment) symptomatic bradycardia currently on HR lowering treatment (for example verapamil, diltiazem, etc.) symptomatic hypotension severe bronchial asthma or severe chronic obstructive pulmonary disease severe forms of peripheral arterial occlusive disease or severe forms of Raynaud's syndrome untreated phaeochromocytoma metabolic acidosis hypersensitivity to Concor® or to any of the excipients. Any contraindication to Concor® according to SmPC

Design outcomes

Primary

MeasureTime frame
Percentage of patients with a reduction of at least 10 % in HRTimepoint: after 6 months of treatment

Secondary

MeasureTime frame
Change of BP at baseline versus end of study assessment Change of the HR and BP at baseline versus end of study assessment in different patient groups: diabetics, non-diabetics, smokers, non-smokers, age < 60 , age > 60 Change of HbA1C and lipids at baseline versus end of study assessment in diabetics, non-diabetics, smokers, non-smokers, age < 60 , age > 60Timepoint: after 6 months of treatment

Countries

China, India, Indonesia, Philippines, Singapore, Viet Nam

Contacts

Public ContactHARDIK PARMAR

HEAD -MEDICAL SERVICES

AMIT.GARG@MERCK.CO.IN02266609044

Outcome results

None listed

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