Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
Intervention1: Metosartan: Metosartan – FDC tablets of Metoprolol succinate extended release 25mg + Telmisartan 40mg (Metosartan 25) and Metoprolol succinate extended release 50mg + Telmisartan 40mg (
Sponsors
Sun Pharma Laboratories Limited SPLL
Eligibility
Inclusion criteria
Inclusion criteria: • Male or female patients aged between 18 and 65 years (both inclusive) willing to provide written informed consent. • Patients diagnosed with essential hypertension with co-existing stable ischemic heart disease [no change in severity of symptoms or nitrate consumption in previous 3 months and defined as either stable symptoms (angina or dyspnea), which are thought to be related to chronic arterial disease (CAD), or asymptomatic patients with prior-diagnosed CAD]. • Patients with uncontrolled essential hypertension [having seated diastolic BP (SeDBP) 90 to 110 mmHg and/or seated systolic BP (SeSBP) 140 to 200 mmHg based on in-clinic blood pressure AND 24-hr average SBP = 130 and/or DBP = 80 mmHg based on ABPM], heart rate of >70 beats/minute and who is on stable dose of antihypertensive monotherapy for at least 4 weeks. •Patients recommended FDC of Metoprolol succinate extended release + Telmisartan as part of physician’s clinical decision, in line with the prescribing information (PI) of Metosartan. • Female subjects of childbearing potential must have a negative urine pregnancy test prior to study entry and must be willing to use acceptable method of 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. Acceptable method of contraception includes (e.g., barrier method with spermicide). The calendar method or usage of intra-uterine device (IUD) will not be considered as an acceptable method. The patient must be willing to practice recommended and acceptable method of contraception to prevent pregnancy from the time of study entry till 2 weeks post the last dose of study medication.
Exclusion criteria
Exclusion criteria: • Presence of any clinically relevant known comorbid conditions like hepatic impairment, chronic renal failure, thromboembolic disorders, cerebrovascular diseases, uncontrolled diabetes, uncontrolled thyroid disorder etc. • Any known cardiac disease/disorder like severe bradycardia, heart block greater than first degree or significant first-degree block, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome without pacemaker etc. in which either Metoprolol or Telmisartan (individually or in combination) is contraindicated. • Presence or history of secondary or malignant hypertension. • Female subjects who are pregnant or lactating or are likely to become pregnant • Patients receiving other beta blocker therapy (other than Metoprolol) in the last 4 weeks of treatment period prior to entering the study • Any relevant clinical condition which, in the opinion of the investigator, could interfere with the outcome of the study. • Patients expected to be non-compliant to the recommended instructions of the treating physician. • Concomitant or prior (within 60 days of screening) use of any of the following medications: calcium channel blockers, digitalis glycosides, MAO inhibitors, fluoxetine, paroxetine, propafenone, quinidine, ACE inhibitors, clonidine, aliskiren. • Patients who have participated in any study of an investigational product within last months. • Subjects with known intolerance, hypersensitivity or any other contraindication to any of Metoprolol or Telmisartan.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the mean 24-hr SBP and DBP from baseline to 8 weeks on ambulatory blood pressure measurement (ABPM).Timepoint: 8 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| • Responder rates (BP target of 130/80 mm Hg as per 2017 American College of Cardiology [ACC] guidelines for hypertension) based on mean 24-hour ambulatory blood pressure measurement (ABPM). • Responder rates (BP target of 130/80 mm Hg) based on in-clinic blood pressure measurements. • Change in mean of SBP and DBP from baseline to 8 weeks for last 6-hr dosing interval (relative to dose time). • Change in heart rate from baseline to 8 weeks. • Proportion of patients achieving the target heart rate (Target heart rate is defined as 60 beats/min and 50 beats/min [range 50 – 60 beats/min]) at the end of study period • Change in short term blood pressure variability measured at each visit • Change in 24 hr distribution of BP reduction measured at each visit • Change in evaluation of early morning BP levels – First 6 hours vs last 3 hours BP difference, calculated from the time of application of ABPM device. Timepoint: 8 Weeks | — |
Countries
India
Contacts
Public ContactDr Amol Prabhudesai
Sun Pharma Laboratories Limited (SPLL)
Outcome results
None listed