A Clinical trial to Study the effects of 3 different doses of Azilsartan Medoxomil 20mg, 40mg and 80 mg in comparison with 2 different doses Telmisartan 20mg and 40 mg in Indian patients with high blood pressure.
- Conditions
- Health Condition 1: null- Adults patients of Essential hypertension with or without associated Cardiovascular Complications
- Registration Number
- CTRI/2015/01/005346
- Lead Sponsor
- MSN Laboratories Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 255
1.Male or female patients of age between 18-65 years.
2.Patients or patientâ??s legally acceptable representative willing to sign the Informed Consent Form.
3.Patients newly diagnosed (first-time diagnosis during screening or within three months before the first day of screening) with Essential Hypertension of Stage 1 with SBP ranging between 140 159 mmHg and / or DBP ranging between 90-99 mmHg.
4.Patients currently:
a) on anti-hypertensive drug therapy (for phase A as well as phase B) or
b) without anti-hypertensive drug therapy (for phase B only)
5.Female patients of childbearing potential who are sexually active must agree to use adequate contraception, and should neither be pregnant nor lactating from screening throughout the duration of the study
6.Patients willing and able to participate in all aspects of the core study, including use of oral medication, completion of subjective evaluations, and compliance with protocol requirements.
7.Patients willing to discontinue current anti-hypertensive drug therapy (if applicable).
1.Patients (essentially â??newly diagnosedâ??) who will be at a significant medical risk arising out of deprivation of regular anti-hypertensive drug treatment during the washout period.
2.Patients with a history of chronic kidney disease, renal artery stenosis, excessive aldosterone secretion, pheochromocytoma, or sleep apnea.
3.Patients with severe renal impairment (eGFR <60 mL/min/1.73 m2).
4.Patients with severe hepatic impairment [SGOT, SGPT and S. Bilirubin (total) >=1.5 times the upper limit of normal reference values].
5.Patients with history of hyperkalemia.
6.Patient with known history of unstable cardiovascular disease and/or signi�cant cardiac conduction defects.
7.Patient with Type 1 or Type 2 Diabetes Mellitus.
8.Known history of gout.
9.Patients suffering from pre-existing severe cough.
10.Patients with history of cardiac surgery in past 3 months prior to screening.
11.Known or suspected hypersensitivity to any drug that will be administered during the study.
12.Inability to comply with the protocol requirements.
13.Participation in any other clinical trial within 3 months of registering in this trial.
14.Have any condition or situation that, in the opinion of the investigator, would prevent proper evaluation of the safety of the study drug according to the study protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy: <br/ ><br>Mean reduction in the trough sitting clinic SBP and DBP from baseline to Day 14 (±2) and Day 43(+1) <br/ ><br> <br/ ><br>Safety: <br/ ><br>Percentage of patients reporting AE and/or SAE during the study, its frequency, severity, pattern and causal relationship to the drug.Timepoint: Efficacy: <br/ ><br>Baseline to each post randomization visit [Day1, 14, 42 and 43] <br/ ><br> <br/ ><br>Safety: <br/ ><br>Each post randomization Visit [Days 1, 7, 14, 28, 42 and 43] <br/ ><br>Baseline to each post randomization visit [days 1, 7, 14, 28, 42 and 43]
- Secondary Outcome Measures
Name Time Method Change in 24 hour mean (average of all measurements for 24 hours) SBP and DBP.Timepoint: On day 43 (or 44) as compared to baseline