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

Evaluation of clinical acceptability of the Fixed Dose Combination of Perindopril + Indapamide in moderate to severe hypertension

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/07/009160

Enrollment

150

Registered

2017-07-28

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Fixed Dose Combination of Perindopril & Indapamide: a Treatment initiation dose: FDC of perindopril 4 mg & indapamide 1.25 mg one tablet daily in the morning b Up-titration dose: FDC

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The blood pressure reduction rates from baseline to the end of study with the treatment of the FDC of Perindopril + Indapamide Mean decrease in blood pressure from the baseline in terms of achieving target BP control =140/90 mmHg (among diabetic patients =140/85 mmHg as per ESH/ESC 2013 guidelines). Timepoint: DAY 90	—

Secondary

Measure	Time frame
² Tolerability and acceptability of the treatment in terms of incidence of side effects and treatment complianceTimepoint: DAY 15 AND DAY 90	—

Countries

India

Contacts

Public ContactSofi Joseph

SERDIA PHARMACEUTICALS (INDIA) PVT. LTD.

sofi.joseph@servier.com

Outcome results