Recruiting NCT06625346

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

— Observational Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Fixed-Dose Combination of Amlodipine/Valsartan.
Who it may be relevant to: Registry conditions: Hypertension. Basic parameters: 18 years — 70 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Pakistan
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Official title

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

Overview

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.

Detailed 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.

Interventions

Drug Fixed-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 th

Primary outcome measures

To assess the effectiveness of EXTOR (Amlodipine/Valsartan) in newly diagnosed hypertensive patients in 8 weeks. [Time frame: 8 week]
To assess the Health-Related Quality of Life of newly diagnosed hypertensive patients managed by Extor [Time frame: 8 week]
To assess the overall safety of EXTOR (Amlodipine/Valsartan) in newly diagnosed hypertensive patients. [Time frame: 8 week]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

Pakistan · 2 centers

Kuwait Teaching Hospital — Peshawar
National Medical Centre — Karachi

Identifiers

NCT: NCT06625346 · TSCL-HELP-01

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗