Text Size

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.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01241487
First received: November 15, 2010
Last updated: June 7, 2011
Last verified: June 2011
History of Changes
  Purpose

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: 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

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Safety and Tolerability of the Trial Medication [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • The incidence of Edema [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

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
valsartan/amlodipine
 Drug: valsartan/amlodipine
160/10 mg

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01241487

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

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01241487     History of Changes
Other Study ID Numbers: CVAA489AEG02
Study First Received: November 15, 2010
Last Updated: June 7, 2011
Health Authority: Egypt: Ministry of Health and Population
Egypt: Ministry of Health, Drug Policy and Planning Center

Keywords provided by Novartis:
Hypertension, Valsartan/Amlodipine,

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Valsartan
Amlodipine, valsartan drug combination
Calcium Channel Blockers
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 22, 2013