At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 324 enrolled
Drug / intervention
Telmisartan80mg+Amlodipine5mg +2 moredrug
Likely dose
amlodipine 5mgfrom 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.
8 Week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80mg+ Amlodipine 5 mg vs. Amlodipine 5mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 5mg Monotherapy
In Brief
A Phase 3 clinical trial evaluating Telmisartan80mg+Amlodipine5mg, amlodipine 5mg, and 1 other intervention for Hypertension. Completed, enrolled 324 participants across 16 sites in 3 countries.
Detailed Summary
The primary objectives of this trial is to demonstrate that the fixed-dose combination of telmisartan 80mg plus amlodipine 5mg (T80/A5) is superior to amlodipine 5mg (A5) in reducing seated trough diastolic blood pressure (DBP) at 8 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesChina, Malaysia, Philippines
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2010
Enrollment StartJul 2010
Primary CompletionAug 2011
TodayJul 2026
First PostedApr 15, 2010
Enrollment StartJul 1, 2010
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 16.2 years ago
Interventions
Telmisartan80mg+Amlodipine5mgdrug
combination therapy
amlodipine 5mgdrug
monotherapy
Telmisartan80mg+Amlodipine 5mgdrug
combination therapy