A Multicentric Randomized Double Blind Double Dummy Parallel Group Comparative Phase III Clinical Study to Evaluate the Efficacy Safety & Tolerability

Phase 3

• Conditions: Health Condition 1: I159- Secondary hypertension, unspecified

• Registration Number: CTRI/2022/09/046074
• Lead Sponsor: Ajanta Pharma Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Male or female subjects aged between 18 and 75 years (both inclusive).

2.Subjects those who are uncontrolled on FDC of Metoprolol succinate 50 mg + Amlodipine 5 mg.

3.Subjects with the history of uncontrolled essential hypertension [having seated diastolic BP (SeDBP) 90 to 110 mmHg and seated systolic BP (SeSBP) 140 to 180 mmHg] who is on the stable dose of two antihypertensive medications in recommended dose for atleast 4 weeks.

4.As judged by the Investigator, based on a clinical evaluation performed during the screening period.

5.Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.

6.Female subjects of childbearing potential must be willing to use acceptable method of contraception or post-menopausal for at least one year or surgically sterile.

Exclusion Criteria

Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation.

Subjects with EF <40% as per Simpsonâ??s method on 2D Echo.

Subjects diagnosed with Secondary or Malignant Hypertension.

Surgical or medical condition that, in the judgment of the Investigator or Sponsor, could interfere with absorption, distribution, metabolism, or excretion of the drugs to be used.

Study & Design

• Study Type: Interventional
• Study Design: Not specified