Phase 3
Completed N=531
Filtered Trial for Amlodipine Non-responder
Source: ClinicalTrials.gov NCT00558064 ↗Enrolled (actual)
531
Serious AEs
0.6%
Results posted
Feb 2010
Primary outcomePrimary: Reduction From Reference Baseline in Mean Seated Diastolic Blood Pressure at Trough (24-hour Post-dosing) — 9.56; 4.45 mmHg — p=<0.0001
Summary
To demonstrate that a fixed-dose combination of telmisartan 40 mg plus amlodipine 5 mg is superior to amlodipine 5 mg alone in patients with essential hypertension and inadequately controlled with amlodipine 5 mg monotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction From Reference Baseline in Mean Seated Diastolic Blood Pressure at Trough (24-hour Post-dosing) |
9.56; 4.45 | <0.0001 sig |
| SECONDARY Reduction From Reference Baseline in Mean Seated Systolic Blood Pressure at Trough (24-hour Post-dosing) |
13.04; 5.77 | — |
| SECONDARY Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline) |
68.1; 47.1 | — |
| SECONDARY Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline) |
67.1; 45.8 | — |
| SECONDARY Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline) |
74.5; 50.2 | — |
| SECONDARY Percentage of Patients Who Achieved an Adequate Response in Seated Trough Systolic Blood Pressure at 8 Weeks |
79.5; 58.4 | — |
| SECONDARY Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline) |
11.0; 1.6; 24.3; 9.7; 26.6; 23.0 | — |
| SECONDARY Clinically Relevant Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG |
1; 0; 1; 0; 2; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Essential hypertensive patients satisfying all of the following criteria;
- Male or Female
- Age > 20 years
- Outpatient
- Patients who are able to stop current anti-hypertensive therapy at Visit 1 if taking any anti-hypertensive medications
- Patients with an ability to provide written informed consent in accordance with the related laws and guidelines such as Good Clinical Practice (GCP) and the Pharmaceutical Affairs Law.
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 (NCT00558064). 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.