A prospective, multicentre, open-label, single armobservational study of Concor® treatment in Asian patientswith Essential Hypertensio
- Registration Number
- CTRI/2010/091/002813
- Lead Sponsor
- Merck Pte Ltd3 International Business Park #02-01Nordic European CentreSingapore 609927
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1000
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients with a reduction of at least 10 % in HRTimepoint: after 6 months of treatment
- Secondary Outcome Measures
Name Time Method Change of BP at baseline versus end of study assessment<br> Change of the HR and BP at baseline versus end of study assessment in different<br>patient groups: diabetics, non-diabetics, smokers, non-smokers, age < 60 , age > 60<br> Change of HbA1C and lipids at baseline versus end of study assessment in<br>diabetics, non-diabetics, smokers, non-smokers, age < 60 , age > 60Timepoint: after 6 months of treatment