Phase 3
N=324
An Eight-week Randomized,Double-blind Study to Evaluate the Efficacy and Safety of Fixed-dose Combinations of T80+A5 Versus A5 Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With A5 Monotherapy
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01103960 ↗Enrolled (actual)
324
Serious AEs
0.0%
Results posted
Sep 2012
Primary outcome: Primary: Change From Baseline in DBP After 8 Weeks of Treatment — -10.19; -12.38 mmHg — p=0.007
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Telmisartan80mg+Amlodipine5mg (Drug); amlodipine 5mg (Drug); Telmisartan80mg+Amlodipine 5mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in DBP After 8 Weeks of Treatment |
-10.19; -12.38 | 0.007 sig |
| PRIMARY Change From Baseline in DBP After 8 Weeks of Treatment in Chinese Patients |
-8.85; -10.77 | 0.034 sig |
| SECONDARY Change From Baseline in SBP After 8 Weeks of Treatment |
-11.66; -16.15 | <0.001 sig |
| SECONDARY DBP and SBP Control and Response After 8 Weeks of Treatment |
85; 112; 100; 119; 101; 124 | — |
| SECONDARY Number of Patients in Blood Pressure Categories Over Time |
7; 11; 33; 36; 32; 53 | — |
| SECONDARY Change From Baseline in DBP After 4 Weeks of Treatment |
-7.51; -9.41 | — |
| SECONDARY Change From Baseline in SBP After 4 Weeks of Treatment |
-8.19; -12.10 | — |
| SECONDARY DBP and SBP Control and Response After 4 Weeks of Treatment |
71; 95; 91; 103; 87; 108 | — |
| SECONDARY Number of Patients in Blood Pressure Categories at 4 Weeks |
1; 7; 20; 26; 35; 44 | — |
| SECONDARY Clinically Relevant Abnormalities for Physical Examination, Pulse Rate, Laboratory Parameters and ECG. |
0; 1; 1; 0; 1; 4 | — |
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.
Eligibility Criteria
Inclusion criteria
- diagnosis of essential hypertension
- failure to respond adequately to six weeks treatment with amlodipine 5 mg monotherapy
- provision of written informed consent
Exclusion criteria
- clinical conditions which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine for the planned duration of this trial (e.g. populations where labeling of either product recommends against its utilization)
Data sourced from ClinicalTrials.gov (NCT01103960). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.