A Phase III, Clinical Trial to Evaluate the safety, tolerability and efficacy of 2 Fixed dose combinations of Azelnidipine and Olmesartan when compared with fixed dose combination of Amlodipine and Olmesartan in patients with Stage II hypertension.
- Conditions
- Health Condition 1: I159- Secondary hypertension, unspecified
- Registration Number
- CTRI/2020/01/023062
- Lead Sponsor
- Synokem Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 210
1.Patients of either sex aged between 18 to 75 years
2.Signed written informed consent obtained prior to inclusion in the study.
3.Patient diagnosed with Stage II hypertension (SBP >=160 to <=180 and DBP >=100 to <=110 mmHg)) not adequately responding to hypertension monotherapy or Subjects who are newly diagnosed with hypertension who have not received anti-hypertensive medication for at least 2 weeks prior to Visit 1
4.Subjects willing to adhere to protocol and study requirements during the entire study duration
5.Subjects having no abnormalities in general physical examination
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method