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A Year Long Study to Evaluate the Safety of the Combination of Valsartan (320 mg) and Amlodipine (5 mg) in Patients With Hypertension

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ClinicalTrials.gov Identifier: NCT00170976
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : November 8, 2011
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Description
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Brief Summary:
A ONE YEAR SAFETY STUDY FOR PATIENTS WHO COMPLETE STUDY VAA489A2307.

Condition or disease Intervention/treatment Phase
HYPERTENSION Drug: valsartan + amlodipine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 403 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 54 Week, Extension to the Double-blind, Multicenter, Multifactorial, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Valsartan (160 mg and 320 mg) and Amlodipine (10 mg) Combined and Alone in Hypertensive Patients
Study Start Date : April 2004
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Adverse events and serious adverse events at each study visit for 6 or 12 months

Secondary Outcome Measures :
  1. Change from baseline in diastolic blood pressure from baseline after 6 or 12 months
  2. Change from baseline in systolic blood pressure from baseline after 6 or 12 months
  3. Change from baseline in standing diastolic and systolic blood pressure after 6 or 12 months
  4. Change from baseline in sitting and standing pulse after 6 or 12 months
  5. Hematology and blood chemistry after 6 or 12 months

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • SUCCESSFUL COMPLETION OF VAA489A2307 CORE TRIAL
  • VISIT 7 BLOOD PRESSURE MUST BE MSDBP ≤ 95 mmHg AND MSSBP ≤ 150 mmHg

Exclusion Criteria:

  • PATIENTS WHO EXPERIENCED ANY ADVERSE EVENTS CONSIDERED SERIOUS AND DRUG RELATED IN VAA489A2307 CORE

Other protocol-defined exclusion criteria may apply.

Contacts and Locations
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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): NCT00170976


Locations
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Germany
Sites in germany
Investigative Centers, Germany
Switzerland
Novartis Pharmaceuticals
Basel, Switzerland
Sponsors and Collaborators
Novartis
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00170976     History of Changes
Other Study ID Numbers: CVAA489A2307E1
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: November 2011
Keywords provided by Novartis:
HYPERTENSION, VALSARTAN, AMLODIPINE< SAFETY
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Valsartan
Antihypertensive Agents
Calcium Channel Blockers
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists