Phase 3
N=858
Telmisartan and Amlodipine Fixed Dose Combination [FDC] Trial for the Treatment of Severe Hypertension
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00860262 ↗Enrolled (actual)
858
Serious AEs
0.8%
Results posted
Jan 2011
Primary outcome: Primary: Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 — -47.5; -36.9; -43.2 mmHg (millimeters of mercury) — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- amlodipine (Drug); telmisartan (Drug); telmisartan and amlodipine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 |
-47.5; -36.9; -43.2 | <0.0001 sig |
| SECONDARY Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6 |
-46.9; -36.3; -42.1 | <0.0001 sig |
| SECONDARY Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4 |
-44.5; -34.4; -39.8 | <0.0001 sig |
| SECONDARY Change From Baseline in Trough Seated Systolic Blood Pressure at Week 2 |
-37.9; -30.1; -33.3 | <0.0001 sig |
| SECONDARY Change From Baseline in Trough Seated Systolic Blood Pressure at Week 1 |
-31.9; -25.4; -28.6 | <0.0001 sig |
| SECONDARY Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) at Week 8 |
-18.7; -13.8; -16.3 | — |
| SECONDARY Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6 |
-18.3; -13.5; -15.7 | — |
| SECONDARY Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 4 |
-17.0; -12.1; -14.2 | — |
| SECONDARY Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 2 |
-13.2; -10.4; -11.4 | — |
| SECONDARY Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 1 |
-10.9; -8.2; -9.6 | — |
| SECONDARY Patients Achieving Diastolic Blood Pressure Control at Week 1 |
147; 61; 64; 240; 146; 143 | — |
| SECONDARY Patients Achieving Diastolic Blood Pressure Control at Week 2 |
205; 87; 91; 200; 125; 121 | — |
| SECONDARY Patients Achieving Blood Pressure Control at Week 1 |
54; 16; 15; 333; 191; 192 | — |
| SECONDARY Patients Achieving Blood Pressure Control at Week 2 |
88; 30; 28; 317; 182; 184 | — |
| SECONDARY Patients Achieving Diastolic Blood Pressure Response at Week 1 |
232; 95; 100; 155; 112; 107 | — |
| SECONDARY Patients Achieving Diastolic Blood Pressure Response at Week 2 |
289; 123; 128; 116; 89; 84 | — |
| SECONDARY Patients Achieving Systolic Blood Pressure Response at Week 1 |
338; 164; 173; 49; 43; 34 | — |
| SECONDARY Patients Achieving Systolic Blood Pressure Response at Week 2 |
387; 169; 189; 18; 43; 23 | — |
| SECONDARY Number of Patients Achieving Various Blood Pressure Response Levels at Week 1 |
3; 0; 0; 9; 3; 3 | — |
| SECONDARY Number of Patients Achieving Various Blood Pressure Response Levels at Week 2 |
6; 0; 0; 21; 7; 5 | — |
| SECONDARY Patients Achieving Diastolic Blood Pressure Control at Week 4 |
268; 106; 109; 124; 106; 94 | — |
| SECONDARY Patients Achieving Diastolic Blood Pressure Control at Week 6 |
290; 110; 128; 104; 102; 77 | — |
| SECONDARY Patients Achieving Diastolic Blood Pressure Control at Week 8 |
291; 112; 131; 103; 100; 74 | — |
| SECONDARY Patients Achieving Blood Pressure Control at Week 4 |
161; 49; 53; 231; 163; 150 | — |
| SECONDARY Patients Achieving Blood Pressure Control at Week 6 |
196; 54; 77; 198; 158; 128 | — |
| SECONDARY Patients Achieving Blood Pressure Control at Week 8 |
199; 51; 73; 196; 161; 132 | — |
| SECONDARY Patients Achieving Diastolic Blood Pressure Response at Week 4 |
339; 132; 151; 53; 80; 61 | — |
| SECONDARY Patients Achieving Diastolic Blood Pressure Response at Week 6 |
356; 144; 168; 38; 68; 37 | — |
| SECONDARY Patients Achieving Diastolic Blood Pressure Response at Week 8 |
361; 147; 172; 34; 65; 33 | — |
| SECONDARY Patients Achieving Systolic Blood Pressure Response at Week 4 |
388; 180; 194; 4; 32; 9 | — |
| SECONDARY Patients Achieving Systolic Blood Pressure Response at Week 6 |
388; 184; 201; 6; 28; 4 | — |
| SECONDARY Patients Achieving Systolic Blood Pressure Response at Week 8 |
391; 188; 202; 4; 24; 3 | — |
| SECONDARY Patients Achieving Normal Blood Pressure Response at Week 4 |
15; 4; 2; 47; 15; 14 | — |
| SECONDARY Patients Achieving Normal Blood Pressure Response at Week 6 |
17; 5; 3; 73; 19; 18 | — |
| SECONDARY Patients Achieving Normal Blood Pressure Response at Week 8 |
18; 3; 2; 76; 21; 25 | — |
Summary
The primary objective of this trial is to demonstrate that following eight weeks of treatment the FDC of telmisartan 80 mg plus amlodipine 10 mg (T80/A10) is superior as first line therapy in reducing mean seated trough cuff Systolic Blood Pressure [SBP] compared to the monotherapies of telmisartan 80 mg (T80) and amlodipine 10 mg (A10) in patients with severe hypertension. A key secondary objective is to identify the duration of treatment required to demonstrate the superiority of the FDC over both of the monotherapies.
Eligibility Criteria
Inclusion criteria
- Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation
- Age 18 years or older
- Patients with severe hypertension as defined SBP greater than 180 mmHg and DBP greater than 95 mmHg at randomisation
- Ability to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigators discretion)
Exclusion criteria Mean in-clinic seated cuff SBP >/= 200 mmHg and/or Diastolic Blood Pressure [DBP] >/= 95 mmHg
Data sourced from ClinicalTrials.gov (NCT00860262). 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.