Study of Efficacy and Safety of CVAA489 in Hypertensive Patients

Study Overview
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Brief Summary
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The population that will be included in this study, will be regular Turkish hypertensive patients who are expected to consume sodium in high amounts. It is hypothesized that, in that population, amlodipine/valsartan will be effective at the same rate of blood pressure (BP) control rate as expected from literature.

Official Title
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A Single-Arm Open-Label Multicenter Phase IV Clinical Trial to Explore the Blood Pressure Lowering Effect of Exforge® (Amlodipine/Valsartan: AMLO/VAL) in Hypertensive Patients

Conditions
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Essential Hypertension

Intervention / Treatment
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* Drug: amlodipine/valsartan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, above 18 years of age Diagnosis of essential hypertension Newly diagnosed, Previously untreated, or Currently untreated (not on regular antihypertensive treatment during the previous at least 1-month period) Written informed consent Exclusion Criteria: Known or suspected secondary hypertension eGFR lower than 30 mL/min Use of any other hypertension treatments during the enrollment and need for using the related treatments during the study phase History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. (i.e. valsartan, amlodipine, hydrochlorothiazide) History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days until the expected PD effect has returned to baseline, whichever is longer.Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: amlodipine/valsartan<br>All patients will receive amlodipine/valsartan 5/160 mg daily in screening and up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (day 30) if their hypertension can not be controlled. The duration of treatment period is 8 weeks. | Drug: amlodipine/valsartan<br>* Fixed combination of amlodipine and valsartan in tablet; 5/160/mg, 10/160 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8 | Control rate of BP defined as BP lower than 140/90 mmHg at office visits | At week 4 and 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8 | Change in systolic blood pressure measured in office from baseline at week 4 and 8. | baseline, week 4, week 8 | 
| Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8 | Change in diastolic blood pressure measured in office from baseline at week 4 and week 8. | baseline, week 4, week 8 | 
| Percentage of Participants With High Sodium Intake and Blood Pressure (BP) <140/90 mmHg at Week 4 and 8 | Control rate of BP is defined as blood pressure lower than 140/90 mmHg at office visits in patients with high sodium intake (>100 mEq/day) | At week 4 and 8 | 
| SBP and DBP in Patients With High Sodium Intake at Week 4 and 8 | Change in systolic and diastolic blood pressure measured in office from baseline at week 4 and 8. | At week 4 and 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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essential hypertension