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Safety, Tolerability, and Efficacy of Once Daily Amlodipine/Valsartan 5/80 as Compared to Amlodipine/Valsartan 5/40 or to Amlodipine 5 mg Monotherapy in Patients 65 Years of Age and Older With Essential Hypertension

This study is currently recruiting participants.
Verified by Novartis, June 2008

Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00699192
  Purpose

To characterize the safety, tolerability, and efficacy profile of amlodipine/valsartan 5/80 mg as compared to amlodipine/valsartan 5/40 mg (with optional titration to 5/80 mg) and amlodipine 5 mg monotherapy in elderly patients (≥ 65 years of age) with essential hypertension. All three regimens are expected to be well tolerated.


Condition Intervention Phase
Hypertension
Drug: amlodipine and valsartan
Drug: amlodipine 5 mg
Phase III

MedlinePlus related topics:   High Blood Pressure   

ChemIDplus related topics:   Valsartan    Amlodipine    Amlodipine besylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:   A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of Once Daily Amlodipine/Valsartan 5/80 mg as Compared to Amlodipine/Valsartan 5/40 mg or to Amlodipine 5 mg Once Daily in Elderly Patients With Essential Hypertension Not Adequately Controlled After Four Weeks on Amlodipine 5 mg Once Daily

Further study details as provided by Novartis:

Primary Outcome Measures:
  • The overall reporting of adverse events, serious adverse events (SAEs) including death, discontinuation due to adverse events, and notable laboratory abnormalities. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate: aml/val 5/80mg compared to aml 5 mg monotherapy, [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • To evaluate aml/val 5/40mg to aml 5 mg monotherapy [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • To evaluate blood pressure lowering effects [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • To evaluate changes in orthostatic blood pressure, sitting and standing pulse, and laboratory data [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:   670
Study Start Date:   May 2008
Estimated Study Completion Date:   June 2009
Estimated Primary Completion Date:   June 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Active Comparator Drug: amlodipine and valsartan
amlodipine + valsartan 5/80, once daily at 8am for 8 weeks
2: Active Comparator Drug: amlodipine and valsartan
amlodipine + valsartan 5/40 mg once daily at 8am for four or 8 weeks
3: Active Comparator Drug: amlodipine 5 mg
amlodipine 5 mg once daily for 8 weeks

  Eligibility
Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Patients must give written informed consent before any assessment is performed.
  • Male or female ages 65 years and older.
  • Diagnosed as having hypertension:
  • Visit 3/Core double-blind treatment period entry, all patients MUST have a mean seated SBP ≥145 mmHg and <180 mmHg.
  • Ability to communicate and comply with all study requirements including measuring their blood pressure at home, daily as instructed, using the home blood pressure monitor provided by the Sponsor.
  • Female patients must be post-menopausal for at least one year.

Exclusion Criteria:

  • Patients with severe hypertension (mean seated SBP ≥180 mmHg and/or a mean seated DBP ≥110 mmHg).
  • Patients who have a history of secondary hypertension (including primary aldosteronism, renovascular hypertension, pheochromocytoma, etc.).
  • Patients receiving three or more antihypertensive drugs. Dual fixed dose combination therapy will be considered as two antihypertensive drugs.
  • Administration of any agent indicated for the treatment of hypertension after Visit 1, with the permitted exception of those antihypertensive medications requiring tapering down (e.g. beta-blocker and/or clonidine) commencing with Visit 1.
  • Known moderate or malignant retinopathy. Moderate defined as: retinal signs of hemorrhage, microaneurysm, cotton-wool spot, hard exudates, or a combination thereof; malignant defined as: signs of moderate retinopathy plus swelling of the optic disk.
  • Known or suspected contraindications, including history of allergy or hypersensitivity to ARBs, CCBs, or to drugs with similar chemical structures.
  • History of cerebrovascular accident, thrombotic stroke, or transient ischemic attack.
  • Significant history of coronary artery disease (CAD) such as any history of myocardial infarction (MI), angina pectoris, and all types of revascularization procedures.

Other protocol-defined inclusion/exclusion criteria may apply" at the end of this section

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699192

Contacts
Contact: Novartis Pharmaceuticals     41.61.324.1111    

Locations
Czech Republic
Novartis Investigative site     Recruiting
      Brno, Czech Republic
      Contact: Novartis Pharmaceuticals     41.61.324.1111        
Investigative sites Czech Republic     Recruiting
      Praha, Czech Republic
      Contact: Novartis Pharmaceuticals     41.61.324.1111        
Investigative sites Czech Repbulic     Recruiting
      Hodonin, Czech Republic
      Contact: Novartis Pharmaceuticals     41.61.324.1111        
Sites in Czech Republic     Recruiting
      Nachod, Czech Republic
      Contact: novartis pharma     41.61.324.1111        
Investigative site Czech Republic     Recruiting
      Chrudim, Czech Republic
      Contact: Novartis pharma     41.61.324.1111        
Investigative site Czech Repbulic     Recruiting
      Jicin, Czech Republic
      Contact: novartis Pharma     41.61.324.1111        
Finland
Investigative site Finland     Recruiting
      Joensuu, Finland
      Contact: Novartis pharma     41.61.324.1111        
Investigative site Finland     Recruiting
      Tampere, Finland
      Contact: Novartis Pharma     41.61.324.1111        
Investigative site Finland     Recruiting
      Kerava, Finland
      Contact: Novartis Pharma            
Investigative site Finland     Recruiting
      Helsinki, Finland
      Contact: Novartis Pharma     41.61.324.1111        
France
Investigative site France     Not yet recruiting
      Paris, France
Germany
Investigative site Germany     Not yet recruiting
      Berlin, Germany
      Contact: Novartis Pharma     41.61.324.1111        
Hungary
Investigative site Hungary     Recruiting
      Budapest, Hungary
      Contact: Novartis Pharma     41.61.324.1111        
Italy
Investigative site Italy     Recruiting
      Rome, Italy
      Contact: Novartis Pharma     41.61.324.1111        
Poland
Investigative site Poland     Not yet recruiting
      Warsaw, Poland
      Contact: Novartis pharma     41.61.324.1111        
Slovakia
Investigative site Slovakia     Recruiting
      Bratislava, Slovakia
      Contact: Novartis Pharma     41.61.324.1111        
Spain
Investigative site Spain     Recruiting
      Valencia, Spain
      Contact: Novartis pharma     41.61.324.1111        
Sweden
Investigative site Sweden     Not yet recruiting
      Malmo, Sweden
      Contact: Novartis pharma     41.61.324.1111        

Sponsors and Collaborators
Novartis

Investigators
Principal Investigator:     Novartis Pharmaceuticals     Sponsor GmbH    
  More Information


Responsible Party:   pharmaceuticals ( Novartis )
Study ID Numbers:   CVAA489A2318
First Received:   June 9, 2008
Last Updated:   June 17, 2008
ClinicalTrials.gov Identifier:   NCT00699192
Health Authority:   Czech Republic: State Institute for Drug Control;   Finland: National Agency for Medicines;   France: Afssaps - French Health Products Safety Agency;   Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM);   Hungary: Országos Gyógyszerészeti Intézet;   Italy: Ministry of Health;   Slovakia: State Institute for Drug Control;   Spain: Spanish Agency of Medicines;   Sweden: Medical Products Agency;   Poland: THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS

Keywords provided by Novartis:
Blood pressure  
hypertension  
elderly  

Study placed in the following topic categories:
Vascular Diseases
Essential hypertension
Valsartan
Amlodipine
Hypertension

Additional relevant MeSH terms:
Membrane Transport Modulators
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Calcium Channel Blockers
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008




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