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

The Searle Company

Status: Enrolling

Conditions: Hypertension

Treatments: Drug: Fixed-Dose Combination of Amlodipine/Valsartan

Study type: Observational

Funder types: Industry

Identifiers

NCT06625346

TSCL-HELP-01

Details and patient eligibility

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.

Full description

To assess the effectiveness of EXTOR (Amlodipine/Valsartan) in newly diagnosed hypertensive patients in 8 weeks.

• Change from Baseline to 8 weeks in Systolic Blood Pressure (SBP) From standard Blood Pressure Measurement.
• Change from Baseline to 8 weeks in Diastolic Blood Pressure (DBP) From standard Blood Pressure Measurement.
• Change from Baseline to 8 weeks in the Health-Related Quality of Life of newly diagnosed hypertensive patients managed by Extor: assess by Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9)
• Change from baseline to 4 weeks in Diastolic Blood Pressure (SBP) From standard Blood Pressure Measurement
• Change from baseline to 4 weeks in Diastolic Blood Pressure (DBP) From standard Blood Pressure Measurement
• Change from baseline to 4 weeks in the Health-Related Quality of Life of newly diagnosed hypertensive patients managed by Extor: assess by Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9)
• To assess the overall safety of EXTOR (Amlodipine/Valsartan) in newly diagnosed hypertensive patients.

Note: The safety is assessed in all subjects who received at least one dose of study drug.

Enrollment: 420 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

420 participants in 1 patient group

Naive Hypertensive patients

Description:

Naive Pakistani subjects diagnosed as the case of Hypertension prescribed Extor in routine practice.

Treatment:

Drug: Fixed-Dose Combination of Amlodipine/Valsartan