Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06625346
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-03-19
Brief Title:
Clinical Response of EXTOR AmlodipineValsartan in Newly Diagnosed Hypertensive Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Outcomes in Newly Diagnosed Hypertensive Patients with EXTOR Fixed-Dose Combination of AmlodipineValsartan in Routine Pakistani Practice
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HELP
Brief Summary:
The American College of CardiologyAmerican 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 2010 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 AmlodipineValsartan 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 AmlodipineValsartan in newly diagnosed hypertensive patients
Note The safety is assessed in all subjects who received at least one dose of study drug
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 AmlodipineValsartan in newly diagnosed hypertensive patients
Note The safety is assessed in all subjects who received at least one dose of study drug
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None