Phase 3
Completed N=259
An Open-label, Long-term Study of Telmisartan Plus Amlodipine Fixed-dose Combination
Source: ClinicalTrials.gov NCT00618774 ↗Enrolled (actual)
259
Serious AEs
4.6%
Results posted
Mar 2010
Primary outcomePrimary: Percentage of Participants Who Experienced Adverse Events — 77.3; 77.1 percentage of participants
Summary
To assess the long term safety and efficacy of telmisartan plus amlodipine FDC in patients with essential hypertension who failed to control their BP with either monotherapy
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Experienced Adverse Events |
77.3; 77.1 | — |
| PRIMARY Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG |
2; 0; 1; 0; 0; 1 | — |
| SECONDARY Change From Baseline in Seated Diastolic Blood Pressure at Week 8 |
20.81; 15.75 | — |
| SECONDARY Change From Baseline in Seated Systolic Blood Pressure at Week 8 |
33.89; 26.44 | — |
| SECONDARY Seated DBP Control Rate at Trough After 8 Weeks |
91.8; 52.1 | — |
| SECONDARY Seated SBP Control Rate at Trough After 8 Weeks |
93.2; 85.4 | — |
| SECONDARY Change From Baseline in Seated Diastolic Blood Pressure |
20.67; 16.36; 21.39; 17.78 | — |
| SECONDARY Change From Baseline in Seated Systolic Blood Pressure |
33.73; 27.18; 33.97; 28.11 | — |
| SECONDARY Seated DBP Control Rate at Trough After 6 and 12 Months |
90.8; 54.2; 92.8; 66.7 | — |
| SECONDARY Seated SBP Control Rate at Trough After 6 and 12 Months |
95.7; 89.6; 93.2; 89.6 | — |
| SECONDARY Seated DBP Response Rate at Trough |
97.1; 85.4; 98.6; 87.5 | — |
| SECONDARY Seated SBP Response Rate at Trough |
97.6; 93.8; 97.6; 93.8 | — |
| SECONDARY Seated Blood Pressure Normalisation at Trough |
29.5; 4.2; 35.3; 18.8; 24.2; 31.3 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with essential hypertension
- Outpatient
Exclusion Criteria
- Patients whose SBP >=180 mmHg or DBP >=110 mmHg at the end of treatment visit of the double-blind treatment period in the "non-responder trials"
- Patients who have met any of the exclusion criteria defined in the "non-responder trials"
Data sourced from ClinicalTrials.gov (NCT00618774). 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.