None listed
Conditions
Interventions
Intervention1: Telmisartan with metoprolol ER: once daily`
Control Intervention1: telmisartan: once daily
Sponsors
M/s. Ravenbhel Healthcare Pvt. Ltd.
Eligibility
Inclusion criteria
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. o Mean supine DBP >= 95 and <= 114 mm Hg at each of Visits 2 and 3. o Mean 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| NilTimepoint: | — |
Countries
India
Contacts
Public ContactDr. Nitin m rathod
Outcome results
None listed