Phase 3
Completed N=314
Filtered Trial for Telmisartan 40mg Non-responder
Source: ClinicalTrials.gov NCT00550953 ↗Enrolled (actual)
314
Serious AEs
0.3%
Results posted
Feb 2010
Primary outcomePrimary: Decrease in Seated Diastolic Blood Pressure From Baseline to 8 Weeks — 13.49; 5.47 mmHg — p=<0.0001
Summary
The primary purpose of this study is to:
Demonstrate that a fixed-dose combination of telmisartan 40 mg plus amlodipine 5 mg is superior to telmisartan 40 mg alone in patients with essential hypertension and inadequately controlled with telmisartan 40 mg monotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Decrease in Seated Diastolic Blood Pressure From Baseline to 8 Weeks |
13.49; 5.47 | <0.0001 sig |
| SECONDARY Decrease in Seated Systolic Blood Pressure From Baseline to 8 Weeks |
17.86; 6.51 | — |
| SECONDARY Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline) |
78.4; 46.8 | — |
| SECONDARY Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline) |
81.2; 37.1 | — |
| SECONDARY Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline) |
85; 50 | — |
| SECONDARY Percentage of Patients Who Achieved an Adequate Response in Seated Trough Systolic Blood Pressure at 8 Weeks (0 Percent at Baseline) |
89.5; 58.2 | — |
| SECONDARY Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline) |
17.0; 3.2; 30.7; 17.1; 26.1; 17.1 | — |
| SECONDARY Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG |
1; 0; 1; 0; 0; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Essential hypertensive patients who satisfying non-responder criteria
- Male or Female
- Age 20 years or older
- Outpatient
Exclusion Criteria
- Taking four or more anti-hypertensive medications
- Secondary hypertension
- Mean seated diastolic blood pressure (DBP) > 114 mmHg and/or mean seated systolic blood pressure (SBP) > 200 mmHg at Visit 1, 2, 3, or 4, or mean seated DBP 120% during the run-in period
- Receiving any investigational therapy within 3 months
- Judged to be inappropriate by the investigator or the sub-investigator
Data sourced from ClinicalTrials.gov (NCT00550953). 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. Informational only — not medical advice.