NCT00819104

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
402

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

September 9, 2009

Status Verified

September 1, 2009

First QC Date

January 7, 2009

Last Update Submit

September 7, 2009

Conditions

Primary Hypertension

Keywords

Primary hypertensionMetoprolol XLAmlodipine

Outcome Measures

Primary Outcomes (1)

  • Change in BP with Selomax™ 50/5 at the end of the randomisation treatment period.

    8 weeks

Secondary Outcomes (3)

  • Change in BP (SBP,DBP & mean BP) with SelomaxTM 25/2.5 at the end of the randomisation period.

    8 weeks

  • Change in the heart rate,Number of responders & control rates.

    8 weeks

  • 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

    8 weeks

Study Arms (5)

1

EXPERIMENTAL

FDC of Metoprolol XL 50mg + Amlodipine 5mg

Drug: Metoprolol XL 50mg + Amlodipine 5mg

2

EXPERIMENTAL

FDC of Metoprolol XL 25mg + Amlodipine 2.5mg

Drug: Metoprolol XL 25 mg + Amlodipine 2.5mg

3

ACTIVE COMPARATOR

Extended release Metoprolol succinate

Drug: Metoprolol XL 50mg

4

ACTIVE COMPARATOR

Extended release Metoprolol succinate

Drug: Metoprolol XL 25 mg

5

ACTIVE COMPARATOR

Amlodipine 5mg in immediate release formulation

Drug: Amlodipine 5mg

Interventions

Metoprolol XL 50mg + Amlodipine 5mgDRUG

tablet,oral,OD,8 weeks

Also known as: Selomax 50/5
1
Metoprolol XL 25 mg + Amlodipine 2.5mgDRUG

tablet,oral,OD,8 weeks

Also known as: Selomax 25/2.5
2
Metoprolol XL 50mgDRUG

tablet,oral,OD,8 weeks

Also known as: Revelol XL
3
Metoprolol XL 25 mgDRUG

tablet,oral,OD,8 weeks

Also known as: Revelol XL
4
Amlodipine 5mgDRUG

tablet,oral,OD,8 weeks

Also known as: Amlogard
5

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Research Site

Hyderabad, Andhra Pradesh, India

Location

Research Site

Ahmedabad, Gujarat, India

Location

Research Site

Bangalore, Karnataka, India

Location

Research Site

Calicut, Kerala, India

Location

Research Site

Mumbai, Maharashtra, India

Location

Research Site

Pune, Maharashtra, India

Location

Research Site

Delhi, National Capital Territory of Delhi, India

Location

Research Site

Jaipur, Rajasthan, India

Location

Research Site

Lucknow, Uttar Pradesh, India

Location

Research Site

Kolkata, West Bengal, India

Location

Research Site

Bangalore, India

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 7, 2009

First Posted

January 8, 2009

Study Start

November 1, 2008

Study Completion

August 1, 2009

Last Updated

September 9, 2009

Record last verified: 2009-09

Locations

IN(11)