Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Telmisartan (40mg) +Metoprolol-s(125mg): Subjects will be administered daily one dose of Tablet S-Metoprolol (25mg) and Telmisartan(40mg)
Sponsors
EMCURE PHARMACEUTICALS
Eligibility
Inclusion criteria
Inclusion criteria: 1 Patients aged greater than or equal to 18 to less than or equal to 65 years willing to provide a signed informed consent document 2 Patients uncontrolled having a SBP of greater than or equal to 140 mmHg and DBP greater than or equal to 90 mmHg despite treatment on Telmisartan 40 mg treatment period of 4 weeks with elevated resting heart rate greater than 80 bpm measured in OPD set up using cuff sphygmomanometer Or 3 Patients considered appropriate to participate in the study as per the clinical judgement of the investigator 4 Male or females patients who are non menopausal agrees to follow adequate contraceptive methods during the study period
Exclusion criteria
Exclusion criteria: 1 Presence of any clinically relevant disease or disorder e g severe hepatic impairment chronic renal failure thromboembolic disorders coronary artery or cerebrovascular diseases uncontrolled diabetes uncontrolled thyroid disorder etc 2 Patients of T2DM 3 Patients of T1DM 4 Surgical or medical condition that in the judgment of the Investigator could interfere with absorption distribution metabolism or excretion of the drugs to be used 5 Presence or history of secondary or malignant hypertension 6 Any known cardiac disease disorder in which any study medication is contraindicated 7 Current or recent substance abuse including alcohol 8 Refusal or inability to comply with the requirements of the protocol for any reason including scheduled clinic visits and laboratory tests 9 Participation in any experimental drug study within 60 days before screening 10 Concomitant or prior within 60 days of screening use of any of the following medications calcium channel blocker clonidine aliskiren 11 Subjects having intolerance hypersensitivity or any other contraindication to any of the Investigational products 12 History of HIV Hepatitis B
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Chang in the mean 24-hr SBP and DBP on ABPM 2 Change in the resting Heart RateTimepoint: 1 from baseline to End of the study visit 2 from baseline to End of the study visit | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 The reduction from the reference in the mean daytime 06:00 21:59 SBP and DBP on 24-h ABPM after 8 2 The reduction from the reference in the mean nighttime 22:00 05:59 SBP and DBP on 24-h ABPM after 8 weeks of the treatmment 3 The reduction from the reference in the mean morning 06:00 11:59 SBP and DBP on 24-h ABPM 4 The reduction from the reference baseline in the clinic mean seated SBP and DBP 5 Percentage drop in mean BP from day time to night time 6 Smoothness Index for SBP and DBP based on 24-h ABPM Timepoint: 1 Baseline to End of the treatment visit 2 Baseline to End of the treatment visit 3 Baseline to End of the treatment visit 4 Baseline to End of the treatment visit | — |
Countries
India
Contacts
Public ContactMr Chandu Gangadhar Devanpally
Ardent Clinical Research Services
Outcome results
None listed