Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
None listed
Sponsors
Dr Reddys Laboratories Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with mild to moderate essential hypertension (as per IGH 2019) where ABPM is indicated for subject as a clinical measurement requirement. 2. Male or female between 18 and 65 years of age 3. Patients having mild to moderate essential hypertension who are treatment-naïve or are uncontrolled (i.e. BP goal not met after one month of antihypertensive therapy) with their current antihypertensive therapy and are prescribed amlodipine as add-on therapy.
Exclusion criteria
Exclusion criteria: 1. Patients with secondary hypertension. 2. Patient on other CCBâ??s. 3. Patients who are Non ambulatory. 4. Patients with known hypersensitivity to Amlodipine. 5. Pre-menopausal women who have no birth control, who are pregnant or nursing. 6. Patients with advanced hepatic impairment or advanced renal impairment. 7. Patients with New York Heart Association (NYHA) functional class III or IV congestive heart failure (CHF), unstable angina, acute myocardial infarction, heart surgery or stroke within the previous six months. 8. Patients with any type of relevant arrhythmia according to the assessment of the investigator. 9. Patients with any valvular disease with hemodynamic repercussion. 10. Patients receiving chronic administration of oral anticoagulants or digoxin. 11. Patients with severe, uncontrolled hypertension or any form of secondary hypertension. 12. Patients with any other clinical conditions which, in the opinion of the investigator, would not allow for the safe completion of the protocol. 13. Patient who refuse to give informed consent. 14. Patients are actively participating in another medical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the mean 24-hr SBP and DBP on ABPM in patient with mild to moderate essential hypertension who are treatment-naïve or are uncontrolled (i.e. BP goal not met after one month of antihypertensive therapy) with their current antihypertensive therapy and are prescribed amlodipine as add-on therapy.Timepoint: After 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Efficacy Endpoints 1. Change from baseline in mean morning SBP and DBP 2. Change from baseline in daytime mean for SBP and DBP 3. Change from baseline in night-time mean for SBP and DBP 4. Change from baseline in mean of SBP and DBP for last 6-hr dosing interval (relative to dose time). Secondory Safety Endpoint: Safety will be assessed based on the spontaneous reports generated by the patients/clinician and will be reported as per local regulatory guidelines.Timepoint: After 8 weeks | — |
Countries
India
Contacts
Public ContactRavindra Kale
Dr. Reddys Laboratories Limited
Outcome results
None listed