A clinical trial to study the effects of two drugs, Fixed-Dose Combination of Telmisartan and Metoprolol Succinate ER with Telmisartan Alone in Patients of Essential Hypertensio

Phase 3

Completed

• Registration Number: CTRI/2010/091/000148
• Lead Sponsor: M/s. Ravenbhel Healthcare Pvt. Ltd.

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: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

?Male and female outpatients ³ 18 years of age.
?Females must be either irreversibly sterilized or post-menopausal as defined by the absence of menstruation for at least 24 months.
?Essential hypertensive patients who meet the following criteria.
oMean supine DBP >= 95 and <= 114 mm Hg at each of Visits 2 and 3.
oMean supine systolic blood pressure (SBP) must be >= 140 and <= 200 mm Hg at Visit 3.
?Able to stop current antihypertensive therapy without risk to the patient.
?Patients who are able and are willing to comply with the protocol and have signed IEC or IRB approved Informed Consent Form.
?Patients who are able to adequately maintain the diary.

Exclusion Criteria

?Not willing to sign the ICF,
?Known or suspected secondary hypertension.
?Mean SBP equal to or greater than 200 mmHg
?Patients with abnormal clinical chemistry, hematology, urinalysis, or ECG test results that are considered clinically significant by the investigator or the sponsor.
?Patients with significant hepatic disease (liver function tests x 2 upper limit of normal reference range) or significant renal disease (creatinine x 2 upper limit of normal reference range).
?Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients post-renal transplant or with only one functioning kidney
?Uncorrected volume or sodium depletion or hyponatremia
?Primary aldosteronism
?Hereditary fructose intolerance
?Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists
?History of drug or alcohol dependency within the previous six months. Chronic administration of any medication known to affect blood pressure, other than the trial medication
?Concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form.
?Symptomatic congestive heart failure (New York Heart Academy (NYHA) functional class CHF II-IV) - unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery less than three months prior to informed consent
?Stroke less than six months prior to informed consent
?Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant arrhythmias as determined by the investigator.
?Hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve
?Insulin-dependent diabetes mellitus whose diabetes has not been stable and controlled for the previous three months
?Night-shift workers who routinely sleep during the daytime and whose working hours include midnight to 4: 00 AM
?Known allergic hypersensitivity to any component of the formulations under investigation
?Concomitant therapy with lithium, cholestyramine or colestipol resins. non-compliance with study medication (defined as less than 80% or more than 120%) during the run-in period
?Current treatment with any antihypertensive agent
?Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan or Metoprolol
?Patients being treated with any of the excluded medications mentioned in the protocol.
?Patients with concomitant diseases such as malignancy, HIV
?Pregnancy and lactation.
?Females of childbearing potential may not be recruited.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To investigate whether a fixed-dose combination of 20 mg of the angiotensin receptor II antagonist telmisartan plus 25 mg of the beta-blocker Metoprolol Succinate ER is superior to 20 mg telmisartan alone in patients with mild to moderate hypertension.Timepoint: 8 weeks

Secondary Outcome Measures

Name	Time	Method
ilTimepoint: