Study of Efficacy and Safety of CVAA489 in Hypertensive Patients

February 7, 2017 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Novartis Investigative Site
      • Canakkale, Turkey
        • Novartis Investigative Site
      • Fatih / Istanbul, Turkey, 34098
        • Novartis Investigative Site
      • Kinikli / Denizli, Turkey, 20070
        • Novartis Investigative Site
      • Kocaeli, Turkey, 41380
        • Novartis Investigative Site
      • Malatya, Turkey, 44280
        • Novartis Investigative Site
      • Mersin, Turkey, 33079
        • Novartis Investigative Site
      • Talas / Kayseri, Turkey, 38039
        • Novartis Investigative Site

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

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: amlodipine/valsartan
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
Fixed combination of amlodipine and valsartan in tablet; 5/160/mg, 10/160 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8
Time Frame: 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
Time Frame: baseline, week 4, week 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
Time Frame: baseline, week 4, week 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

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

February 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

February 12, 2014

First Submitted That Met QC Criteria

February 12, 2014

First Posted (Estimate)

February 14, 2014

Study Record Updates

Last Update Posted (Actual)

March 28, 2017

Last Update Submitted That Met QC Criteria

February 7, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVAA489ATR04

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.

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