At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 976 enrolled
Drug / intervention
telmisartan/amlodipine 40/5 mg fixed combination +1 moredrug
Likely dose
telmisartan/amlodipine 40/5 mg fixed combinationfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label Follow-up Trial of the Efficacy and Safety of Chronic Administration of the Combination of Telmisartan 40mg + Amlodipine 5mg or the Combination of Telmisartan 80mg + Amlodipine 5mg Tablets Alone or in Combination With Other Antihypertensive Medications in Patients With Hypertension.
In Brief
A Phase 3 clinical trial evaluating telmisartan/amlodipine 40/5 mg fixed combination and telmisartan/amlodipine 80/5 mg fixed combination for Hypertension. Completed, enrolled 976 participants across 122 sites in 12 countries.
Detailed Summary
The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40 mg / amlodipine 5 mg (T40/A5) or telmisartan 80 mg / amlodipine 5 mg (T80/A5) during long-term open-label treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesBelgium, Canada, Denmark, Finland, France, Netherlands, Norway, Philippines, South Africa, South Korea, Sweden, Taiwan
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2008
First PostedFeb 2008
Primary CompletionMar 2009
TodayJul 2026
First PostedFeb 13, 2008
Enrollment StartJan 1, 2008
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 18.4 years ago
Interventions
telmisartan/amlodipine 40/5 mg fixed combinationdrug
telmisartan/amlodipine 80/5 mg fixed combinationdrug