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 Hypertension
- Conditions
- Essential (primary) hypertension,
- Registration Number
- CTRI/2021/11/037926
- Lead Sponsor
- Micro Labs Limited
- Brief Summary
This is a Randomized, Double Blind, Parallel Group,Multicentric, Phase-III clinical study to compare the Efficacy, Safety andTolerability of FDC of Telmisartan 40mg + Bisoprolol 5 mg tablets versus FDC ofTelmisartan 40mg + Metoprolol Succinate ER 50 mg tablets in the treatment ofStage 1 and Stage 2 Hypertension
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 264
- 1.Patients aged 18-65 years of age of both gender 2.Subject with essential hypertension with seated systolic BP (SeSBP) ≥140 to ≤180 mmHg and having seated diastolic BP (SeDBP) ≥ 90 to ≤ 110 mmHg (Stage 1 and Stage 2 Hypertension, Indian Hypertension Guidelines –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.
- 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 patient’s participation in study.
- 11.Participation in another clinical trial within past 30 days.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •Mean change in Seated Systolic Blood Pressure (SeSBP) from baseline to Week-12 •Mean change in Seated Systolic Blood Pressure (SeSBP) from baseline to Week-12 | •Mean change in Seated Diastolic Blood Pressure (SeDBP) from baseline to Week-12 •Mean change in Seated Diastolic Blood Pressure (SeDBP) from baseline to Week-12 •Mean change in Seated Systolic Blood Pressure (SeSBP) from baseline to Week-12 | •Mean change in Seated Diastolic Blood Pressure (SeDBP) from baseline to Week-12
- Secondary Outcome Measures
Name Time Method Proportion of subjects achieving Seated Systolic Blood Pressure (SeSBP) less than 140 mmHg from baseline to Week-12 Proportion of subjects achieving Seated Diastolic Blood Pressure (SeDBP) less than 90 mmHg from baseline to Week-12
Trial Locations
- Locations (10)
Dayanand Medical College & Hospital, Ludhiana
🇮🇳Ludhiana, PUNJAB, India
GCS Medical College, Hospital & Research Center
🇮🇳Ahmadabad, GUJARAT, India
Govt Medical College and Govt General Hospital, (Old RIMSGGH)
🇮🇳Srikakulam, ANDHRA PRADESH, India
Indira Gandhi Institute of Medical Sciences
🇮🇳Patna, BIHAR, India
King Georges Medical University
🇮🇳Lucknow, UTTAR PRADESH, India
KMC Hospital
🇮🇳Kannada, KARNATAKA, India
Kovai Diabetes Speciality Centre & Hospital
🇮🇳Coimbatore, TAMIL NADU, India
Life Care Hospital and Research Centre
🇮🇳Bangalore, KARNATAKA, India
NH-Rabindranath Tagore International Institute of Cardiac Sciences
🇮🇳Kolkata, WEST BENGAL, India
Sri Jayadeva Institute of Cardiovascular Sciences and Research
🇮🇳Bangalore, KARNATAKA, India
Dayanand Medical College & Hospital, Ludhiana🇮🇳Ludhiana, PUNJAB, IndiaDr Gurpreet S WanderPrincipal investigator01614688800apigswander@gmail.com