Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
Intervention1: FDC of Cilnidipine 20 mg plus Telmisartan 40 mg Film-Coated Tablets: One tablet once daily around the same time may be taken with or without food every day for 12 weeks.
Control Interve
Sponsors
Ajanta Pharma Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female subjects aged between 40 to 65 years (both inclusive). 2.Subjects diagnosed with essential hypertension not controlled on maximum tolerated dose of CCB or ARB monotherapy and having seated diastolic BP (SeDBP)90 to 110 mmHg and seated systolic BP (SeSBP) 140 to 180 mmHg. 3.Female subjects of childbearing potential using adequate contraception. 4.Subjects with the ability to understand and provide a written informed consent form, which must have been obtained prior to screening. 5.Subjects willing to comply with the protocol requirements.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.The assessment of the safety of subjects [Based on the incidence of treatment-emergent adverse event (TEAE)]. 2.The assessment of the tolerability of the study drug will be based on the incidence of AEs and SAEs and changes in laboratory values. 3.Mean change in SeSBP between baseline and 12 weeks. 4.Mean change in SeDBP between baseline and 12 weeks. Timepoint: baseline and 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving SeSBP less than 140 mmHg (SeSBP responder) [Time frame: 8 and 12 weeks]. Proportion of subjects achieving SeDBP less than 90 mmHg (SeDBP responder) [Time frame: 8 and 12 weeks].Timepoint: 8, 12 weeks | — |
Countries
India
Contacts
Public ContactDr Neeta Nargundkar
Biosphere Clinical Research Pvt Ltd
Outcome results
None listed