RecruitingNCT06625346

Clinical Response of EXTOR (Amlodipine/Valsartan) in Newly Diagnosed Hypertensive Patients.

Clinical Outcomes in Newly Diagnosed Hypertensive Patients With EXTOR (Fixed-Dose Combination of Amlodipine/Valsartan) in Routine Pakistani Practice.


Sponsor

The Searle Company Limited Pakistan

Enrollment

420 participants

Start Date

Sep 28, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The American College of Cardiology/American Heart Association hypertension guidelines recommend treatment initiation with dual antihypertensive therapy in adults with stage 2 hypertension (corresponding to grade 1 and 2 in the ESH classification) and an average BP \>20/10 mm Hg above target. Amlodipine and valsartan are two of the most commonly prescribed medications for the treatment of hypertension (high blood pressure). In Pakistan multiple studies were conducted on Hypertension and use of Single Pill Combination in uncontrolled Hypertension. However, no study was conducted to assess the role of Single Pill Combination (SPC) like Amlodipine and Valsartan in newly diagnosed hypertension and to assess their quality of life by patients' satisfaction with their medication after managing the hypertension with the SPC.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria3

  • Patient with a clinical history of Hypertension (systolic blood pressure greater than or equal to 140 mmHg or a diastolic blood pressure greater than or equal to 90 mmHg) and never had antihypertensive treatment.
  • Patient aged ≥18 and ≤70 years inclusive of either sex.
  • Patient with ability to understand and sign written informed consent form.

Exclusion Criteria5

  • • Patients with already on antihypertensive treatment or secondary hypertension
  • Pregnant women or nursing mothers
  • Patients with acute illnesses or psychiatric diagnosis
  • Known hypersensitivity to Extor product, the metabolites, or formulation excipients.
  • Treated with Extor to evaluate safety as per approved prescribing information for Extor in Pakistan.

Interventions

DRUGFixed-Dose Combination of Amlodipine/Valsartan

Amlodipine and valsartan are two of the most commonly prescribed medications for the treatment of hypertension (high blood pressure). Amlodipine is a calcium channel blocker that works by relaxing the blood vessels, while valsartan is an angiotensin receptor blocker that works by blocking the effects of the hormone angiotensin II, which causes blood vessels to constrict. The combination of amlodipine and valsartan in a single pill has been shown to be more effective in lowering blood pressure than either medication alone. This is because the two medications have different mechanisms of action and work together to provide a more comprehensive approach to blood pressure control.


Locations(2)

Kuwait Teaching Hospital

Peshawar, KPK, Pakistan

National Medical Centre

Karachi, Pakistan

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