CTRI/2022/09/045464RecruitingPhase 4
CONTROL – A Phase IV, open-label, multi-centric, non-comparative study to assess the efficacy and tolerability of fixed dose combination (FDC) of metoprolol and telmisartan (Metosartan) in patients with essential hypertension.
Sun Pharma Laboratories Limited SPLL7 sites in 1 country88 target enrollmentStarted: September 16, 2022Last updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 88
- Locations
- 7
- Primary Endpoint
- Change in the mean 24-hr SBP and DBP from baseline to 8 weeks on ambulatory blood pressure measurement (ABPM).
Study Overview
Brief Summary
This is a prospective, open label, multi-centric, single arm study to assess the efficacy and tolerability of fixed dose combination (FDC) of metoprolol and telmisartan (Metosartan) in patients with essential hypertension
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •â€¢ Male or female patients aged between 18 and 65 years (both inclusive) willing to provide written informed consent.
- •â€¢ 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].
- •â€¢ 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.
- •â€¢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.
- •â€¢ 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
- •â€¢ Presence of any clinically relevant known comorbid conditions like hepatic impairment, chronic renal failure, thromboembolic disorders, cerebrovascular diseases, uncontrolled diabetes, uncontrolled thyroid disorder etc.
- •â€¢ 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.
- •â€¢ Presence or history of secondary or malignant hypertension.
- •â€¢ 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.
- •â€¢ Patients expected to be non-compliant to the recommended instructions of the treating physician.
- •â€¢ 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.
- •â€¢ Patients who have participated in any study of an investigational product within last months.
- •â€¢ Subjects with known intolerance, hypersensitivity or any other contraindication to any of Metoprolol or Telmisartan.
Outcomes
Primary Outcomes
Change in the mean 24-hr SBP and DBP from baseline to 8 weeks on ambulatory blood pressure measurement (ABPM).
Time Frame: 8 Weeks
Secondary Outcomes
- •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.)
Investigators
Study Sites (7)
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