Clinical trial NCT02062645: Study of Efficacy and Safety of CVAA489 in Hypertensive Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Essential Hypertension
Keywords: essential hypertension
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-02-14
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8
timeFrame: At week 4 and 8
Secondary outcomes:
measure: Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8
timeFrame: baseline, week 4, week 8
measure: Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8
timeFrame: baseline, week 4, week 8
measure: Percentage of Participants With High Sodium Intake and Blood Pressure (BP) <140/90 mmHg at Week 4 and 8
timeFrame: At week 4 and 8
measure: SBP and DBP in Patients With High Sodium Intake at Week 4 and 8
timeFrame: At week 4 and 8
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Canakkale
country: Turkey
facility: Novartis Investigative Site
city: Fatih / Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Kinikli / Denizli
country: Turkey
facility: Novartis Investigative Site
city: Kocaeli
country: Turkey
facility: Novartis Investigative Site
city: Malatya
country: Turkey
facility: Novartis Investigative Site
city: Mersin
country: Turkey
facility: Novartis Investigative Site
city: Talas / Kayseri
country: Turkey
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: