A Phase-III clinical study to compare the Efficacy, Safety and Tolerability of FDC of Telmisartan 40mg plus Bisoprolol 5 mg tablets versus FDC of Telmisartan 40mg plus Metoprolol Succinate ER 50 mg tablets in the treatment of Stage 1 and Stage 2 Hypertensio

Phase 3

Completed

• Conditions: Health Condition 1: I10- Essential (primary) hypertension

• Registration Number: CTRI/2021/11/037926
• Lead Sponsor: Micro Labs Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-07-28
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 264

Inclusion Criteria

1.Patients aged 18-65 years of age of both gender

2.Subject with essential hypertension with seated systolic BP (SeSBP) ââ?°Â¥140 to ââ?°Â¤180 mmHg and having seated diastolic BP (SeDBP) ââ?°Â¥ 90 to ââ?°Â¤ 110 mmHg (Stage 1 and Stage 2 Hypertension, Indian Hypertension Guidelines ââ?¬â??IV, 2019).

3.Subjects on monotherapy with either ARB (Telmisartan, Olmesartan, Azilsartan, Losartan) or CCBs (Amlodipine, Benidipine, Cilnidipine, Efonidipine, Azilnidipine) or Bisoprolol or Metoprolol since �12 weeks

4.Female subjects of childbearing potential using adequate contraception

5.Willingness to sign written informed consent document

Exclusion Criteria

1.Women of childbearing potential if pregnant (test positive for pregnancy) at screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study

2.Presence of any clinically relevant disease/disorder (e.g. severe hepatic impairment, chronic renal failure, thromboembolic disorders, recent acute myocardial infarction, history of bronchial asthma, severe COPD etc.)

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

4.Has clinical laboratory evaluations (including biochemistry and hematology) are not within the reference range for the testing laboratory and the results are deemed clinically significant by the investigator

5.Subjects who has evidence of a secondary hypertension.

6.Any known cardiac disease/disorder in which any of the study medication is contra-indicated (e.g. severe bradycardia, heart block greater than first degree or significant first degree block, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome without pacemaker etc.)

7.Refusal or inability to comply with the requirements of the protocol for any reason, including scheduled clinic visits and laboratory tests.

8.Any significant illness or drugs that could interfere with study parameters

9.Subject with known allergy or hypersensitivity to any of the components of the formulation

10.Any other condition that in opinion of the investigator does not justify patientââ?¬•s participation in study.

11.Participation in another clinical trial within past 30 days

Study & Design

• Study Type: Interventional
• Study Design: Not specified