A clinical trial to study effect of combination of three drugs, olmesartan, amlodipine & hydrochlorothiazide in comparison with two drugs olmesartan & amlodipine in patients with high blood pressure

Phase 3

• Conditions: Health Condition 1: null- Hypertension

• Registration Number: CTRI/2010/091/001107
• Lead Sponsor: Micro Labs Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 240

Inclusion Criteria

Subjects with mean trough SeBP ≥ 160/100 mmHg (SeSBP ≥ 160 mmHg and SeDBP ≥ 100 mmHg) at screening (Not controlled by mono therapy with Amlodipine/ Angiotensin Receptor Blocker.)

OR

Subjects with mean trough SeBP ≥ 160/100 mmHg (SeSBP ≥ 160 mmHg and SeDBP ≥ 100 mmHg) after washout of prior antihypertensive medication in subjects who discontinued their previous antihypertensive medication.

Subjects freely sign the informed consent form (ICF) after the nature of the study and the disclosure of his/her data has been explained.

Female subjects of childbearing potential must be using adequate contraception (female of childbearing potential is defined as one who has not been postmenopausal for at least one year, or has not been surgically sterilized, or has not had a hysterectomy at least three months prior to the start of this study [Visit 1]. Adequate contraceptives include hormonal intra-uterine devices, hormonal contraceptives (oral, depot, patch or injectable), and double barrier methods such as condoms or diaphragms with spermicidal gel or foam

Exclusion Criteria

?Patients with BP ≥180/110 mm Hg with or without treatment.
?Female subjects of childbearing potential who are pregnant or lactating.
?Subjects with serious disorders which may limit the ability to evaluate the efficacy or safety of the investigational products, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematologic or, neurologic, and psychiatric diseases. The same applies for immunocompromised and/or neutropenic subjects.
?Subjects having a history of the following within the last six months: myocardial infarction (MI), unstable angina pectoris, percutaneous coronary intervention, heart failure, hypertensive encephalopathy, cerebrovascular accident (stroke), or transient ischaemic attack.
?Subjects with clinically significant abnormal laboratory values at Screening, including subjects with one or more of the following:
oAspartate aminotransferase (AST) > 3 times upper limit of normal (ULN).
oAlanine aminotransferase (ALT) > 3 times ULN.
oGamma-glutamyl transferase (GGT) > 3 times ULN.
?Subjects with secondary HTN of any aetiology such as renal disease, phaeochromocytoma, or Cushing's syndrome.
?Subjects already taking four or more antihypertensive medications.
?Subjects with a mean trough SeSBP > 145 mmHg or mean trough SeDBP > 95 mmHg while taking three antihypertensive medications.
?Subjects with ECG evidence of 2nd or 3rd degree atrio ventricular (AV) block, atrial fibrillation, or other cardiac arrhythmia (requiring treatment).
?Subjects with severe heart failure (New York Heart Association stage III-IV), clinically significant aortic or mitral valve stenosis, uncorrected coarctation of the aorta, obstruction of cardiac outflow (obstructive, hypertrophic cardiomyopathy) or symptomatic coronary disease.
?Subjects with clinical evidence of renal disease including reno-vascular occlusive disease, nephrectomy and/or renal transplant, bilateral renal artery stenosis, unilateral renal artery stenosis in a solitary kidney, or severe renal impairment as evidenced by CrCl of < 30 mL/min calculated using the Cockcroft and Gault formula.
?Subjects who require or are taking any concomitant medication which may interfere with the objectives of the study.
?Subjects on beta blockers or calcium channel blockers (CCBs) for both hypertension and either ischemia, post-MI prophylaxis or tachyarrhythmias.
?Subjects with psychiatric or emotional problems, which would invalidate the giving of informed consent or limit the ability of the subject to comply with study requirements.
?Subjects who have received any investigational agent within 30 days prior to Screening.
?Subjects with signs or symptoms which could exacerbate the occurrence of hypotension such as volume and salt depletion.
?Subjects with any medical condition, which in the judgment of the Investigator would jeopardise the evaluation of efficacy or safety and/or constitute a significant safety risk to the subject.
?Subjects with angioedema.
?Subjects on alcohol or drug abuse.
?Subjects with macroalbuminuria indicative of overt nephropathy.
?Subjects with known hypersensitivity to any of the study drugs

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change in Diastolic Blood Pressure from baseline <br/ ><br> <br/ ><br>Mean change in Systolic Blood Pressure from baselineTimepoint: 12 weeks

Secondary Outcome Measures

Name	Time	Method
Proportion of patients achieving JNC 7-recommended BP goal (<140/90 mm Hg; <130/80 mm Hg for patients with diabetesTimepoint: 12 weeks