A Study to Compare the Efficacy, Safety and Tolerability of Selomax With Its Individual Components

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)

Interventions

  • Drug: Metoprolol XL 50mg + Amlodipine 5mg
    • tablet,oral,OD,8 weeks
  • Drug: Metoprolol XL 25 mg + Amlodipine 2.5mg
    • tablet,oral,OD,8 weeks
  • Drug: Metoprolol XL 50mg
    • tablet,oral,OD,8 weeks
  • Drug: Metoprolol XL 25 mg
    • tablet,oral,OD,8 weeks
  • Drug: Amlodipine 5mg
    • tablet,oral,OD,8 weeks

Arms, Groups and Cohorts

  • Experimental: 1
    • FDC of Metoprolol XL 50mg + Amlodipine 5mg
  • Experimental: 2
    • FDC of Metoprolol XL 25mg + Amlodipine 2.5mg
  • Active Comparator: 3
    • Extended release Metoprolol succinate
  • Active Comparator: 4
    • Extended release Metoprolol succinate
  • Active Comparator: 5
    • Amlodipine 5mg in immediate release formulation

Clinical Trial Outcome Measures

Primary Measures

  • Change in BP with Selomax™ 50/5 at the end of the randomisation treatment period.
    • Time Frame: 8 weeks

Secondary Measures

  • Change in BP (SBP,DBP & mean BP) with SelomaxTM 25/2.5 at the end of the randomisation period.
    • Time Frame: 8 weeks
  • Change in the heart rate,Number of responders & control rates.
    • Time Frame: 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
    • Time Frame: 8 weeks

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Collaborator
    • St. John’s Research Institute
  • Provider of Information About this Clinical Study
    • Dr. Paurus M Irani; VP Medical & Regulatory, AstraZeneca Pharmaceuticals India Ltd.

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