Clinical trial NCT00819104: A Study to Compare the Efficacy, Safety and Tolerability of Selomax With Its Individual Components
Official title: A Five-arm, Randomised, Open Label, Multi-centre, Prospective Study to Compare the Efficacy, Safety and Tolerability of Metoprolol XL Plus Amlodipine Combination (Selomax TM) With Metoprolol XL and Amlodipine as Individual Components in Management of Hypertension in Indian Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Primary Hypertension
Keywords: Primary hypertension
Metoprolol XL
Amlodipine
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: St. John's Research Institute
First posted: 2009-01-08
Enrollment: 402
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomised, open-label; parallel group, multicentric study comparing the efficacy and safety of fixed-dose-combinations of Metoprolol XL plus Amlodipine with individual components of the combination. SelomaxTM50/5 will also be compared with SelomaxTM 25/2.5 in lowering of BP (SBP and DBP) in Indian patients with essential hypertension.Male and female patients of essential hypertension aged between 18-80 years will be studied. The patients should not have a history of prior cardiovascular disease.


Eligibility criteria: Inclusion Criteria:

* Patients of hypertension (primary) , as judged by 2 BP measurements before randomisation
* Those who have given their written consent for the study.

Exclusion Criteria:

* Patients of other forms of hypertension (other than primary)
* Those who have consistently BP \> /=180/120mmHg
* Patients with a prior history of chest pain, heart attacks, conduction defects and strokes.
* Patients of diabetes requiring insulin,asthma and kidney diseases.

Primary outcomes:
measure: Change in BP with Selomax™ 50/5 at the end of the randomisation treatment period.
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in BP (SBP,DBP & mean BP) with SelomaxTM 25/2.5 at the end of the randomisation period.
timeFrame: 8 weeks
measure: Change in the heart rate,Number of responders & control rates.
timeFrame: 8 weeks
measure: Incidence of adverse events (serious and non-serious) in each arm.Change in hemogram, serum chemistry (Liver function tests (LFT), Renal function tests (RFT), plasma lipids, Blood Glucose, HbA1c), and Ur.albumin
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Research Site
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Research Site
state: Gujarat
city: Bangalore
country: India
facility: Research Site
state: Karnataka
city: Calicut
country: India
facility: Research Site
state: Kerala
city: Mumbai
country: India
facility: Research Site
state: Maharashtra
city: Poona
country: India
facility: Research Site
state: Maharashtra
city: Jaipur
country: India
facility: Research Site
state: Rajasthan
city: Lucknow
country: India
facility: Research Site
state: Uttar Pradesh
city: Kolkata
country: India
facility: Research Site
state: West Bengal
city: Bangalore
country: India
facility: Research Site
city: Delhi
country: India
facility: Research Site
Study officials:
References: