Back to resultsA National Multicentre Study to Assess the Efficacy of the Fixed Combination of Valsartan and Amlodipine in Hypertensive Patients Not Controlled by Monotherapy
Primary Purpose
Primary Hypertension
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
valsartan/amlodipine
Sponsored by
About this trial
This is an interventional treatment trial for Primary Hypertension focused on measuring Hypertension, Valsartan/Amlodipine,
Eligibility Criteria
Inclusion Criteria:
- Patient uncontrolled by mono-therapy for at least 8 weeks, having B.P.>/= 140/90 mmHg in non diabetics or >/= 130/80 mmHg in diabetics
Exclusion Criteria:
- Patient having B.P.>= 180/110 mmHg in non diabetics or >= 160/100 mmHg in diabetics
- Type 1 Diabetes or uncontrolled type 2 Diabetes.
- PCI in last 12 months.
- Concomitant unstable angina. Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- Dr Ahmed Anwar Clinic,
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
valsartan/amlodipine
Outcomes
Primary Outcome Measures
Hypertension in patients that will be controlled on each concentration and those that will switch to the higher concentration (160/10)
Secondary Outcome Measures
Hypertension of patients that were previously controlled on (160/5) and those that were uncontrolled and switched to the higher concentration (160/10) after 4 weeks on (160/5) concentration.
Safety and Tolerability of the Trial Medication
The incidence of Edema
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01241487
Brief Title
A National Multicentre Study to Assess the Efficacy of the Fixed Combination of Valsartan and Amlodipine in Hypertensive Patients Not Controlled by Monotherapy
Official Title
An 8 Weeks Open Label National Multicentre Study to Assess the Efficacy of the Fixed Combination of Valsartan and Amlodipine in Hypertensive Patients Not Controlled by Monotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is to assess the efficacy of the fixed combination of Valsartan and Amlodipine in hypertensive patients uncontrolled by monotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypertension
Keywords
Hypertension, Valsartan/Amlodipine,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
valsartan/amlodipine
Intervention Type
Drug
Intervention Name(s)
valsartan/amlodipine
Intervention Description
160/10 mg
Primary Outcome Measure Information:
Title
Hypertension in patients that will be controlled on each concentration and those that will switch to the higher concentration (160/10)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Hypertension of patients that were previously controlled on (160/5) and those that were uncontrolled and switched to the higher concentration (160/10) after 4 weeks on (160/5) concentration.
Time Frame
8 weeks
Title
Safety and Tolerability of the Trial Medication
Time Frame
8 weeks
Title
The incidence of Edema
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient uncontrolled by mono-therapy for at least 8 weeks, having B.P.>/= 140/90 mmHg in non diabetics or >/= 130/80 mmHg in diabetics
Exclusion Criteria:
Patient having B.P.>= 180/110 mmHg in non diabetics or >= 160/100 mmHg in diabetics
Type 1 Diabetes or uncontrolled type 2 Diabetes.
PCI in last 12 months.
Concomitant unstable angina. 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
Dr Ahmed Anwar Clinic,
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
A National Multicentre Study to Assess the Efficacy of the Fixed Combination of Valsartan and Amlodipine in Hypertensive Patients Not Controlled by Monotherapy
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