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

NCT06625346 | Recruiting

• 1 other identifier: TSCL-HELP-01
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypertension

Keywords

Hypertnsion; Amlodipine valsartan combination; Quality of life (QoL); Pakistan

Outcome Measures

Primary Outcomes (3)

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

  * Change from Baseline to 4 week and 8 weeks in Systolic Blood Pressure (SBP) From standard Blood Pressure Measurement. The achieve BP control defined as systolic BP less than 140 mmHg at any of their clinic visits and maintained at the 8 week of treatment clinic visit. * Change from Baseline to 4 week and 8 weeks in Diastolic Blood Pressure (DBP) From standard Blood Pressure Measurement. The achieve BP control defined as Diastolic BP less than 90 mmHg at any of their clinic visits and maintained at the 8 week of treatment clinic visit.

  8 week

• To assess the Health-Related Quality of Life of newly diagnosed hypertensive patients managed by Extor

  • Change from Baseline to 4 week and 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). For TSQM-9 questionnaire applies to assesses patient satisfaction with Extor medication including Effectiveness (3 items), Convenience (2 items), Side effects (2 items) and Global satisfaction (2 items). The TSQM-9 score from 01 to 07. The 01 score (minimum) is Extremely Dissatisfied and Score 07 (maximum) is Extremely Satisfied

  8 week

• To assess the overall safety of EXTOR (Amlodipine/Valsartan) in newly diagnosed hypertensive patients.

  Safety \& tolerability will assess based on the incidence of reported TEAEs by system organ class ; preferred term, as well as by categories: TEAE, severe TEAE, serious TEAE, drug-related TEAE, drug-related severe TEAE, drug-related serious TEAE, TEAE leading to discontinuation, \& TEAE with outcome of death. Drug-related TEAEs were defined as TEAEs assigned a Study Drug (Extor) relationship of adverse reaction \& suspected adverse reaction. TEAEs were coded using the Medical Dictionary for Regulatory Activities, version 19.0. The severity of TEAEs are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03. TEAEs were defined as any adverse event that started or increased in severity after the first dose of Study Drug on Day 1 through the Final Study Visit (8 weeks +/-3 days after last dose).

  8 week

Study Arms (1)

Naive Hypertensive patients

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

Drug: Fixed-Dose Combination of Amlodipine/Valsartan

Interventions

Fixed-Dose Combination of Amlodipine/Valsartan DRUG

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 than either medication alone. This is because the two medications have different mechanisms of action and work together to provide a more comprehensive approach to blood pressure control.

Also known as: EXTOR

Naive Hypertensive patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Searle Company Limited Pakistan: lead

Study Sites (2)

Kuwait Teaching Hospital

Peshawar, KPK, Pakistan

RECRUITING

National Medical Centre

Karachi, Pakistan

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Valsartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Asif Mahmood, MBBS, MPH

  The Searle Company Limited Pakistan

  STUDY DIRECTOR

Central Study Contacts

ALI Y Khanzada, MBBS, MSc

CONTACT

922137170200; ali.yasir@searlecompany.com

Ayesha Ashal, Doctor of Pharmacy

CONTACT

ayesha.ashal@searlecompany.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: October 3, 2024
• Study Start: September 28, 2024
• Primary Completion: August 30, 2025
• Study Completion: September 15, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)