Phase 3
Completed N=976
Open Label Study Telmisartan and Amlodipine in Hypertension
Source: ClinicalTrials.gov NCT00614380 ↗Enrolled (actual)
976
Serious AEs
2.0%
Results posted
Jan 2010
Primary outcomePrimary: Trough Seated Diastolic Blood Pressure (DBP) Control — 504; 160; 19; 84 Participants
Summary
The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40 mg / amlodipine 5 mg (T40/A5) or telmisartan 80 mg / amlodipine 5 mg (T80/A5) during long-term open-label treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough Seated Diastolic Blood Pressure (DBP) Control |
504; 160; 19; 84; 49; 46 | — |
| SECONDARY Trough Seated Systolic Blood Pressure (SBP) Control |
440; 142; 16; 89; 113; 64 | — |
| SECONDARY Change From Baseline in Trough Seated Diastolic Blood Pressure |
-14.18; -12.64; -9.47; -10.17 | — |
| SECONDARY Change in DBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7 |
-3.54; -5.52; -5.51; -5.74 | — |
| SECONDARY Change From Baseline in Trough Seated Systolic Blood Pressure |
-17.79; -15.91; -12.6; -14.04 | — |
| SECONDARY Change in SBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7 |
-4.14; -5.62; -3.6; -7.17 | — |
| SECONDARY Trough Seated DBP Response |
504; 171; 19; 108; 45; 32 | — |
| SECONDARY Trough Seated SBP Response |
490; 179; 18; 128; 59; 24 | — |
| SECONDARY Trough Blood Pressure (BP) Normality Classes |
67; 4; 1; 6; 188; 29 | — |
| SECONDARY Time to First Additional Antihypertensive |
85.8 | — |
| SECONDARY Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control |
10; 100; 110; 2; 106; 108 | — |
| SECONDARY Additional Reduction in DBP by Use of Additional Antihypertensive Therapy |
-5.73 | — |
| SECONDARY Additional Reduction in SBP by Use of Additional Antihypertensive Therapy |
-7.53 | — |
| SECONDARY Trough DBP Control Pre- and Post- Uptitration |
17; 190; 207; 0; 171; 171 | — |
Eligibility Criteria
Inclusion Criteria
- patients aged at least 18 years
- diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the preceding trial.
- failure to respond to six weeks treatment with Amlodipine 5 mg in the run-in period of the preceding trial.
Exclusion Criteria
- pre-menopausal women who are not surgically sterile; or are nursing or pregnant; or are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study
- development of any medical condition in the preceding trial that in the investigator's opinion could be worsened by treatment with either Telmisartan 40 mg/Amlodipine 5 mg or Telmisartan 80 mg/Amlodipine 5 mg
- discontinuation from the preceding trial because of any adverse event or any other reason
- known or suspected secondary hypertension
- mean seated Systolic Blood Pressure => 180 mmHg and/or mean seated Diastolic Blood Pressure => 120 mmHg at any visit
Data sourced from ClinicalTrials.gov (NCT00614380). 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.