Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
Intervention1: Cinlidipine: 10 mg tablets, once daily in the morning.
Treatment Duration - 12 weeks
Control Intervention1: Amlodipine: 10 mg tablets, once daily in the morning.
Treatment Duration -
Sponsors
Dr Amey Beedkar
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult male or female patients between 18 to 65 years (both agesinclusive). 2. Patients with newly diagnosed hypertension with blood pressuremore than or equal to 140/90 mmHg. 3. Serum creatinine within the normal range defined by the locallaboratory. 4. Patients willing to give their written informed consent to participatein the study. 5. Patients willing to comply with all aspects of the protocol.
Exclusion criteria
Exclusion criteria: 1. Blood pressure more than or equal to 180/110 mmHg. 2. Patients hypersensitive to active or inactive ingredients of investigational products. 3. Patients with uncontrolled diabetes mellitus at screening (uncontrolled defined as patients withHbA1c more than or equal to 8% with or without treatment). 4. Patients with recurrent symptomatic hypotension. 5. Patients with uncontrolled kidney disease requiring dialysis or renal replacement therapy. 6. Apparent/pseudo hypertension due to white coat effect, and medical inertia. 7. Patients with known history of heart failure, and reduce cardiac function. 8. Patients with concomitant causes of edema including, nephropathy, cardiac failure, hepatic cirrhosis, use of antidiabetic medications known to cause edema andhypoalbuminemia due to any other cause, will be excluded by renal and liver function tests, thyroid profile, and baseline echocardiography. 9. Patients with varicose veins. 10. Patients with nephrotic syndrome, hypoproteinemia, or microalbuminuria 11. Female patients who are pregnant, lactating, or planning to become pregnant. 12. Female patients not willing to use acceptable method of contraception. 13. History of clinically significant hematologic, hepatic, biliary obstructive disorders, neurologic(including extra pyramidal disorder), psychiatric, renal, cardiovascular(e.g. bradycardia, severe brady arrythmia, sick-sinus syndrome, atrioventricular block, malignant arrhythmia, severe coronary artery disease, unstable angina, vascular heart disease), endocrine, or other diseases or receiving any medication that, in the opinion of the investigator, would put the patient at risk through study period, or would affect the study analyses. 14. Patients scheduled to undergo surgery during the study period. 15. Patients who have received any intervention in a clinical trial within01 month prior to screening. 16. Patients with history of alcohol and/or drug/substance abuse and current significant alcohol consumption which as per investigators judgment, make the patient ineligible to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| effect of cilnidipine and amlodipine in patients with newly diagnosed hypertension at the end of treatment [Day 84 (±4 days)] as assessed by change from baseline in sitting SBP and DBP.Timepoint: effect of cilnidipine and amlodipine in patients with newly diagnosed hypertension at the end of treatment [Day 84 (±4 days)] as assessed by change from baseline in sitting SBP and DBP. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change from baseline in sitting SBP and DBP on Day 15 (±4 days), Day 30 (±4 days), Day 45 (±4 days), Day 60 (±4 days) and Day 84 (±4 days) in both treatment groups.Timepoint: From Baseline to Day 15, Day 30,Day 45, Day 60 & Day 84;2. Proportion of patients with incidence of pedal edema (right and left) on Day 15 (±4 days), Day 30 (±4 days), Day 45(±4 days), Day 60 (±4 days) and Day 84 (±4 days) in both treatment groups.Timepoint: From Baseline to Day 15, Day 30,Day 45, Day 60 and Day 84;3. Change in spot urine-protein creatinine ratio on Day 84 (±4 days)Timepoint: Day 84 | — |
Countries
India
Contacts
Public ContactDr Amey Beedkar
Kingsway Hospital
Outcome results
None listed