To evaluate clinical acceptability of the Fixed Dose Combination of Perindopril + Indapamide in moderate to severe hypertensio

Phase 4

Completed

• Registration Number: CTRI/2017/07/009160
• Lead Sponsor: Serdia Pharmaceuticals India Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-10-22
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 133

Inclusion Criteria

1.Newly diagnosed untreated hypertensive patients having a baseline blood pressure > 160/100 mm Hg

2.Patients of either sex with age group of 18 to 65 years of age

3.Uncontrolled hypertensive patients with a baseline blood pressure > 140/90 mmHg on monotherapy and/or any other two drug FDC

4.Newly diagnosed hypertensive patients with h/o diabetes wherein tighter BP control is targeted (140/85 mm Hg)

5.Hypertensive patients either on monotherapy / any other FDC with h/o diabetes wherein tighter BP control is targeted (140/85 mm Hg)

6.Patients of either sex with confirmed diagnosis of grade II and above (moderate to severe) hypertension, as per ESC guidelines

7.Ready to provide informed consent and available for follow-up

Exclusion Criteria

1.H/o myocardial infarction within the previous 3 months.

2.H/o cerebrovascular event within previous 3 months.

3.Uncontrolled arrhythmias.

4.Uncontrolled diabetes (Hba1c% more than 7)

5.H/o heart failure

6.Patients with severe impaired renal function serum creatinine levels > 5.3 mg/dl and / or serious liver disorders

7.Patients unwilling to give informed consent

8.Patients with history of hypersensitivity to Perindopril or Indapamide

9.Any contraindication to ACE I and/or Thiazide type diuretic

10.Patients receiving beta blockers for the treatment of hypertension

11.Pregnancy or lactation

12.Patients with any other condition or disease, which in the opinion of the investigator could preclude evaluation of response to study medication or hamper the safety of the trial participant

13.Patients previously enrolled in similar trial in the last 3 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified