Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
Intervention1: Cilnidipine: 10 mg , OD Oral for 30 days
Control Intervention1: Cilacar: 10 mg , OD Oral for 30 days
Sponsors
MACLEODS PHARMACEUTICALS LTD
Eligibility
Inclusion criteria
Inclusion criteria: Patients with essential hypertension with blood pressure more than or equal to 140/90 mmHg Patients who require monotherapy with Cilnidipine 10 mg tablets in the opinion of investigator Serum creatinine within the normal range defined by the local laboratory Patients willing to give their written informed consent to participate in the study Patients willing to comply with all aspects of the protocol
Exclusion criteria
Exclusion criteria: Blood pressure more than or equal to 180/110 mmHg,hypersensitive to active or inactive ingredients of investigational products,uncontrolled diabetes mellitus at screening,symptomatic hypotension,uncontrolled kidney disease requiring dialysis or renal ,replacement therapy,Apparent/pseudo hypertension due to white coat effect, and medical inertia,known history of heart failure, and reduce cardiac function,pedal edema, nephrotic syndrome, hypoproteinemia or microalbuminuria,Female patients who are pregnant, lactating, or planning to become pregnant,patients not willing to use acceptable method of contraception,hematologic, hepatic, biliary obstructive disorders, neurologic psychiatric, renal, cardiovascularendocrine, or other diseases or receiving any medication that, in the opinion of the investigator, would put the patient at riskthrough study period, or would affect the study analyses,scheduled to undergo surgery during the study period,who have received any intervention in a clinical trial within 01 month prior to screening,history of alcohol and/or drug/substance abuse and current significant alcohol Consumption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in sitting SBP and DBP on Day 30 (±4 days) in both treatment groupsTimepoint: 30 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in sitting SBP and DBP on Day 15 (±4 days) in both treatment groups Proportion of patients achieving goal BP during the study in both treatment groups at the end of treatment from baseline (Day 30 [± 4 days]) Change from baseline in body weight, pulse rate, pedal edema and ankle circumference (right and left) on Day 15(±4 days) and Day 30(±4 days) in both treatment groups. Change in spot urine-protein creatinine ratio on Day 30 (±4 days) from baselineTimepoint: 30 Days | — |
Countries
India
Contacts
Public ContactDr Pramod Mundra
Platina Heart Hospital
Outcome results
None listed