A Clinical Study to evaluate the effect of two different combinations of BP medication in patients with uncontrolled BP
Completed
- Conditions
- Essential (primary) hypertension,
- Registration Number
- CTRI/2018/08/015555
- Lead Sponsor
- Current Medical Concepts Pvt Ltd
- Brief Summary
This is an investigator initiated study to evaluate the effect of two different combinations of antihypertensive treatments that are already approved and marketed in India for so long. However, the current study is planned to evaluate the role of combination therapy on BP levels as per the new hypertension guidelines.
The drugs that will be used in this study are as follows: (Telmisartan 40 mg plus Amlodipine 5 mg and Telmisartan 40 mg plus Cilnidipine 10 mg)
This study is planned to be conducted across three centers with a sample size 100.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- a) Adults greater than or equal to 18 years and less than or equal to 70 years old both male and female.
- b) Subjects with uncontrolled BP who are on monotherapy.
- c) Systolic Blood Pressure (SBP) >130 mmHg and Diastolic Blood Pressure (DBP) > 80 mmHg based on three consecutive blood pressure readings d) Any stage of Hypertension.
- e) Willing to give written informed consent.
Exclusion Criteria
- a) Women of child bearing potential b) History of Myocardial infarction, Acute stroke, Acute kidney injury in the last 3 months c) Subjects with history of congestive heart failure.
- d) Subjects with advanced CKD with Serum Creatinine value > 2.5 mg/dL.
- e) History of allergy to calcium channel blockers and angiotensin receptor blockers f) Inability to give informed consent g) Subject with hypertensive crisis (Seated BP greater than or equal to 180/120 mmHg) on the day of screening.
- h) Subjects unwilling/unable to adhere to the study protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the effect of two different treatments on BP levels in Subjects with Hypertension Screening and Week 8 (end of study)
- Secondary Outcome Measures
Name Time Method To assess the safety and tolerability of combination therapy from baseline to end of study Between Baseline to end of study
Trial Locations
- Locations (3)
Apollo DRDO Hospitals
🇮🇳Hyderabad, ANDHRA PRADESH, India
Apollo Hospitals
🇮🇳Hyderabad, ANDHRA PRADESH, India
Apollo Institute of Medical Science and Research
🇮🇳Hyderabad, ANDHRA PRADESH, India
Apollo DRDO Hospitals🇮🇳Hyderabad, ANDHRA PRADESH, IndiaDr Partha SaradhiPrincipal investigator8790277017drparthanephro@gmail.com