Health Condition 1: I159- Secondary hypertension, unspecified
Conditions
Interventions
Intervention1: Azelnidipine IP 16mg plus Metoprolol Succinate IP 47.5mg
Eq. to Metoprolol Tartarate SR 50mg Tablets: Subjects will be instructed to administer, One Tablet Once a Day orally with water
Sponsors
Akums Drugs Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and non-pregnant, non-lactating female subjects between 18 to 65 years of age (both inclusive). 2. Treatment-Naïve subjects or subjects who are on stable dose of antihypertensive medications from last 4 weeks, with mean sitting systolic blood pressure (msSBP) >= 160 mmHg to and mean sitting diastolic blood pressure (msDBP) >= 100 mmHg to 3. Female Subjects, of child bearing potential practicing an acceptable method of birth control such as sexual abstinence, intrauterine device IUD, birth control pills, a double-barrier method, transdermal, injection or implants, non-hormonal or hormonal, condom plus spermicide, diaphragm plus spermicide, or vaginal spermicidal suppository; for the duration of the study as judged by the investigator(s)/study physician and agree to follow the same should be used during treatment. OR Postmenopausal for at least 1 year. OR Surgically sterile (bilateral tubal ligation/bilateral oophorectomy/ hysterectomy has been performed on the Subject). Note: Subjects entering the study who are on hormonal contraceptives must have been on the method for at least 90 days prior to the study and continue the method for the duration of the study. Subjects who had used hormonal contraception and stopped must have stopped no less than 90 days prior to the study. 4. Subjects who are able to understand and give voluntary, written informed consent to participate in this clinical investigation and from whom written consent has been obtained. 5. Subjects shall be willing and able to understand and comply with the requirements of the study, administer the study medication as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.
Exclusion criteria
Exclusion criteria: 1. Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation. 2. Female subjects who are pregnant or lactating or planning to become pregnant during the study period. 3. Female subjects who are not ready to use acceptable contraceptive methods during the course of study. 4. Female subjects with positive urine pregnancy test at screening. 5. Subjects with secondary or malignant hypertension 6. Subjects with myocardial infarction or cerebrovascular disorder within 3 months before informed consent. 7.Subjects with unstable angina pectoris, severe heart failure (NYHA class III or IV) and serious arrhythmia (grade II or III atrioventricular block). 8. Subjects with abnormal eGFR ( 9. Subjects with abnormal Liver Function Test with values more than 2.5 times the upper limit of normal. 10.Subjects with Type 1 Diabetes or Type 2 Diabetes Mellitus with HbA1c value greater than 8% will be excluded from the study. 11. Subjects with known case of Oncological Conditions. 12. Subject with any clinically significant laboratory abnormalities at screening visit. 13. Subjects with any other medical condition that might adversely impact the safety of the study participants or confound the study results. 14. Subjects who consume excessive amounts of alcohol, abuse drugs, or have any condition that would compromise compliance with this protocol. 15. Subjects who have been treated with an investigational drug or investigational device within a period of 4 weeks prior to study entry. 16. Currently taking prohibited concomitant medications(s) listed and inability/unwillingness to discontinue them for the entire study period. 17. Suspected inability or unwillingness to comply with the study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in mean sitting systolic blood pressure (msSBP) at the end of study visit (Week 12).Timepoint: Baseline/Visit 2 (Day 1), Visit 3 (week 2), Visit 4 (well 4), Visit 5 (week 8), End of Study/Visit 6 (Week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Ambulatory Blood Pressure at the end of study/early discontinuation visit (Week 12)Timepoint: Baseline/Visit 2 (Day 1), Visit 3 (week 2), Visit 4 (well 4), Visit 5 (week 8), End of Study/Visit 6 (Week 12);Change from baseline in mean sitting diastolic blood pressure (msDBP) at the end of study visit (Week 12)Timepoint: Baseline/Visit 2 (Day 1), Visit 3 (week 2), Visit 4 (well 4), Visit 5 (week 8), End of Study/Visit 6 (Week 12) | — |
Countries
India
Contacts
Public ContactDr Aditi Datta
Biosite Research Private Limited
Outcome results
None listed