Clinical Response of EXTOR (Amlodipine/Valsartan) in Newly Diagnosed Hypertensive Patients.
Recruiting · NCT06625346 · Observational (researchers observe without assigning treatment) · Lead sponsor: The Searle Company Limited Pakistan
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- • 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.
Where it is running
2 locations listed.
- National Medical Centre - Karachi, Pakistan
- Kuwait Teaching Hospital - Peshawar, KPK, Pakistan