Valsartan and Amlodipine Compared to Losartan and Amlodipine in Hypertensive Patients
Evaluation of Antihypertensive Activity of Valsartan and Amlodipine Compared to Losartan and Amlodipine Through Ambulatory Blood Pressure Monitoring in Moderate Hypertensive Patients in a Randomized, Controlled, Double-Blind Study
1 other identifier
interventional
187
1 country
1
Brief Summary
Hypertensive patients with moderate hypertension have a risk to develop cardiovascular events of 15-20% over a period of 10 years. It is important to reach quickly the advised target, but often this result can be obtained with a combination therapy. Some evidences demonstrate sartans and calcium channels blockers can be very useful and safe, but it is also important to verify which association can give side effects or give some pharmacokinetic interactions that can negatively influence the clinical combination efficacy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2008
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 14, 2008
CompletedFirst Posted
Study publicly available on registry
July 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedJuly 17, 2008
July 1, 2008
7 months
July 14, 2008
July 16, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
24 hours mean, determinated through ABPM; diastolic mean after 4 weeks of losartan 100mg/amlodipine 5mg and valsartan 160mg/amlodipine 5mg treatment
after 4 weeks
Secondary Outcomes (1)
24 hours systolic mean, determinated through ABPM; day systolic and diastolic mean determinated through ABPM; night systolic and diastolic mean determinated through ABPM
after 4 weeks
Study Arms (2)
1
EXPERIMENTALvalsartan/amlodipine
2
ACTIVE COMPARATORlosartan/amlodpine
Interventions
Eligibility Criteria
You may qualify if:
- diastolic blood pressure in sitting position 100 to 109 mmHg and systolic blood pressure \> 140 mmHg at the end of the selection period
You may not qualify if:
- type 2 diabetes mellitus
- heart failure
- AMI in the previous 6 months
- angina pectoris
- secondary hypertension
- malignant hypertension
- women child-bearing potential
- women who are pregnant and lactating
- suspected history of allergy to the sartans or calcium channels blockers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Giuseppe Derosa
Pavia, 27100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Roberto Fogari, MD
University of Pavia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 14, 2008
First Posted
July 16, 2008
Study Start
July 1, 2008
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
July 17, 2008
Record last verified: 2008-07