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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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ClinicalTrials.gov Identifier: NCT01241487
Recruitment Status : Completed
First Posted : November 16, 2010
Last Update Posted : February 23, 2017
Sponsor:
Information provided by:
Novartis

Brief Summary:
This study is to assess the efficacy of the fixed combination of Valsartan and Amlodipine in hypertensive patients uncontrolled by monotherapy.

Condition or disease Intervention/treatment Phase
Primary Hypertension Drug: valsartan/amlodipine Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2009
Primary Completion Date : January 2011
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
valsartan/amlodipine
Drug: valsartan/amlodipine
160/10 mg



Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. Safety and Tolerability of the Trial Medication [ Time Frame: 8 weeks ]
  3. The incidence of Edema [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01241487


Locations
Egypt
Dr Ahmed Anwar Clinic,
Cairo, Egypt
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01241487     History of Changes
Other Study ID Numbers: CVAA489AEG02
First Posted: November 16, 2010    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Novartis:
Hypertension, Valsartan/Amlodipine,

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Valsartan
Amlodipine, Valsartan Drug Combination
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists