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Study of Efficacy and Safety of CVAA489 in Hypertensive Patients

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
amlodipine/valsartan
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring essential hypertension

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

amlodipine/valsartan

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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)
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.

Full Information

First Posted
February 12, 2014
Last Updated
February 7, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02062645
Brief Title
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

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
essential hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
amlodipine/valsartan
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
amlodipine/valsartan
Intervention Description
Fixed combination of amlodipine and valsartan in tablet; 5/160/mg, 10/160 mg
Primary Outcome Measure Information:
Title
Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8
Description
Control rate of BP defined as BP lower than 140/90 mmHg at office visits
Time Frame
At week 4 and 8
Secondary Outcome Measure Information:
Title
Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8
Description
Change in systolic blood pressure measured in office from baseline at week 4 and 8.
Time Frame
baseline, week 4, week 8
Title
Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8
Description
Change in diastolic blood pressure measured in office from baseline at week 4 and week 8.
Time Frame
baseline, week 4, week 8
Title
Percentage of Participants With High Sodium Intake and Blood Pressure (BP) <140/90 mmHg at Week 4 and 8
Description
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)
Time Frame
At week 4 and 8
Title
SBP and DBP in Patients With High Sodium Intake at Week 4 and 8
Description
Change in systolic and diastolic blood pressure measured in office from baseline at week 4 and 8.
Time Frame
At week 4 and 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Novartis Investigative Site
City
Canakkale
Country
Turkey
Facility Name
Novartis Investigative Site
City
Fatih / Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Novartis Investigative Site
City
Kinikli / Denizli
ZIP/Postal Code
20070
Country
Turkey
Facility Name
Novartis Investigative Site
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Novartis Investigative Site
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Facility Name
Novartis Investigative Site
City
Mersin
ZIP/Postal Code
33079
Country
Turkey
Facility Name
Novartis Investigative Site
City
Talas / Kayseri
ZIP/Postal Code
38039
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Study of Efficacy and Safety of CVAA489 in Hypertensive Patients

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