Clinical trial NCT06625346: Clinical Response of EXTOR (Amlodipine/Valsartan) in Newly Diagnosed Hypertensive Patients.
Official title: Clinical Outcomes in Newly Diagnosed Hypertensive Patients With EXTOR (Fixed-Dose Combination of Amlodipine/Valsartan) in Routine Pakistani Practice.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertension
Keywords: Hypertnsion
Amlodipine valsartan combination
Quality of life (QoL)
Pakistan
Lead sponsor: The Searle Company Limited Pakistan
Sponsor class: INDUSTRY
First posted: 2024-10-03
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects will be enrolled as per inclusion/exclusion criteria in the study. The total sample size of the study is 420 subjects with Hypertension for the multiple selected study sites and this will have 95% power to detect mean change from baseline to week 4-and 8 weeks for the evaluation of the effectiveness and overall safety response of Extorl for the Essential Hypertension treatment, assuming a standard deviation of the differences of 15.5, using 0.05 two-sided significance level considering 10% drop-out rate

Brief 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.

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.

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.

Primary outcomes:
measure: To assess the effectiveness of EXTOR (Amlodipine/Valsartan) in newly diagnosed hypertensive patients in 8 weeks.
timeFrame: 8 week
measure: To assess the Health-Related Quality of Life of newly diagnosed hypertensive patients managed by Extor
timeFrame: 8 week
measure: To assess the overall safety of EXTOR (Amlodipine/Valsartan) in newly diagnosed hypertensive patients.
timeFrame: 8 week
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Kuwait Teaching Hospital
state: KPK
city: Karachi
country: Pakistan
facility: National Medical Centre
Study officials:
affiliation: The Searle Company Limited Pakistan
name: Asif Mahmood, MBBS, MPH
role: STUDY_DIRECTOR
References: