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

May 12, 2025 updated by: The Searle Company Limited Pakistan

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

420

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
      • Karachi, Pakistan
        • Recruiting
        • National Medical Centre
        • Contact:
          • Prof. Tariq Ashraf, MBBS, FCPS, FSCAI, FACC
          • Phone Number: 922135845475
          • Email: tariqk313@gmail.com
    • KPK
      • Peshawar, KPK, Pakistan
        • Recruiting
        • Kuwait Teaching Hospital
        • Contact:
          • Abdur Rauf Prof, MBBS, FCPS, FACC, FESC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Naive Hypertensive patients
Naive Pakistani subjects diagnosed as the case of Hypertension prescribed Extor in routine practice.
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 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.
Other Names:
  • EXTOR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the effectiveness of EXTOR (Amlodipine/Valsartan) in newly diagnosed hypertensive patients in 8 weeks.
Time Frame: 8 week
  • 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
Time Frame: 8 week
• 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.
Time Frame: 8 week

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Searle Company Limited Pakistan

Investigators

  • Study Director: Asif Mahmood, MBBS, MPH, The Searle Company Limited Pakistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2024

Primary Completion (Estimated)

August 30, 2025

Study Completion (Estimated)

September 15, 2025

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

October 1, 2024

First Posted (Actual)

October 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 15, 2025

Last Update Submitted That Met QC Criteria

May 12, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSCL-HELP-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on Fixed-Dose Combination of Amlodipine/Valsartan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe