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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

This study has been completed.
Information provided by:
Novartis Identifier:
First received: November 15, 2010
Last updated: February 21, 2017
Last verified: February 2017
This study is to assess the efficacy of the fixed combination of Valsartan and Amlodipine in hypertensive patients uncontrolled by monotherapy.

Condition Intervention Phase
Primary Hypertension
Drug: valsartan/amlodipine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
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

Resource links provided by NLM:

Further study details as provided by Novartis:

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

Estimated Enrollment: 150
Study Start Date: February 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: valsartan/amlodipine
160/10 mg


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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01241487

Dr Ahmed Anwar Clinic,
Cairo, Egypt
Sponsors and Collaborators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: External Affairs, Novartis Pharmaceuticals Identifier: NCT01241487     History of Changes
Other Study ID Numbers: CVAA489AEG02
Study First Received: November 15, 2010
Last Updated: February 21, 2017

Keywords provided by Novartis:
Hypertension, Valsartan/Amlodipine,

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
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 processed this record on May 25, 2017