A clinical trial to study the effects of two drugs, Metoprolol and Olmesartan in patients with essential hypertension.

Phase 3

Completed

• Registration Number: CTRI/2010/091/000072
• Lead Sponsor: 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

1.Male and female outpatients ³ 18 years of age.
2.Females must be either irreversibly sterilized or post-menopausal as defined by the absence of menstruation for at least 24 months.
3.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.
4.Able to stop current antihypertensive therapy without risk to the patient.
5.Patients who are able and are willing to comply with the protocol and have signed IEC or IRB approved Informed Consent Form.
6.Patients who are able to adequately maintain the diary.

Exclusion Criteria

1.Not willing to sign the ICF,
2.Known or suspected secondary hypertension.
3.Mean SBP equal to or greater than 200 mmHg
4.Patients with abnormal clinical chemistry, hematology, urinalysis, or ECG test results that are considered clinically significant by the investigator or the sponsor.
5.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).
6.Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients post-renal transplant or with only one functioning kidney
7.Uncorrected volume or sodium depletion or hyponatremia
8.Primary aldosteronism
9.Hereditary fructose intolerance
10.Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists
11.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
12Concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form.
13.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
14.Stroke less than six months prior to informed consent
15.Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant arrhythmias as determined by the investigator.
16.Hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve
17.Insulin-dependent diabetes mellitus whose diabetes has not been stable and controlled for the previous three months
18.Night-shift workers who routinely sleep during the daytime and whose working hours include midnight to 4: 00 AM
19.Known allergic hypersensitivity to any component of the formulations under investigation
20.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
21.Current treatment with any antihypertensive agent
22.Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of Olmesartan Medoxomil or Metoprolol
23.Patients being treated with any of the excluded medications mentioned in the protocol.
24.Patients with concomitant diseases such as malignancy, HIV
25.Pregnancy and lactation.
26.Females of childbearing potential may not be recruited.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.The primary efficacy parameter will be change from baseline in supine diastolic blood pressure (DBP) at trough (24 hours post-dose) at the last visit during the Double-Blind Period. <br>2.Change from baseline in supine systolic blood pressure at trough at the last observation during double-blind treatment. Change from baseline in sitting systolic and diastolic blood pressure at trough at the last observation during double-blind treatment<br>Timepoint:

Secondary Outcome Measures

Name	Time	Method
1.Number of patients achieving target SBP control. ? treatment responders<br>2.Pulse pressure<br>Timepoint: