An observational study to evaluate the effectiveness of Amlodipine on early monring BP surge in adult patient with mild to moderate essential hypertension.
- Conditions
- Health Condition 1: I10- Essential (primary) hypertension
- Registration Number
- CTRI/2020/08/027402
- Lead Sponsor
- Dr Reddys Laboratories Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method