Phase 3
N=27
Telmisartan+Amlodipine Fixed Dose Combination in Hypertension
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01204398 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: DBP and SBP Change From Baseline in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean — -12.76; -23.82 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- telmisartan+amlodipine fixed dose combination (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY DBP and SBP Change From Baseline in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean |
-12.76; -23.82 | — |
| SECONDARY Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing |
-12.5; -14.7; -13.7; -11.7; -9.9; -11.7 | — |
| SECONDARY Trough to Peak (T/P) Ratio for DBP and SBP After 8 Weeks of Treatment |
1.13; 0.98 | — |
| SECONDARY Change From Baseline to End of Study in DBP and SBP |
-9.67; -13.49; -13.73; -11.04; -17.95; -19.80 | — |
| SECONDARY ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing |
101.6; 101.7; 100.0; 97.9; 95.3; 96.5 | — |
| SECONDARY Treatment Emergent Adverse Events |
4; 0; 1; 0 | — |
| SECONDARY Change From Baseline to End of Study in In-clinic Pulse Rate |
2.37 | — |
Summary
The primary objectives of this trial is to evaluate the changes from baseline (Visit 2) in the 24-hour Ambulatory Blood Pressure Monitoring mean (relative to dose time) for diastolic blood pressure and systolic blood pressure after 8 weeks of treatment with Telmisartan 80mg/Amlodipine 5mg in patients with moderate to severe hypertension
Eligibility Criteria
Inclusion criteria
- Aged at least 18 years at the date of signing the consent form
- For treatment-naïve patients: hypertension defined by a mean seated diastolic blood pressure (DBP) equal or more than 100 mmHg measured by manual cuff sphygmomanometry at visit 1 and 2; For pretreatment patients: hypertension defined by a mean seated diastolic blood pressure equal or more than 90 mmHg at visit 1 and equal or more than 100 mmHg at visit 2 measured by manual cuff sphygmomanometry
- 24-hour mean diastolic blood pressure equal or more than 85 mmHg at baseline Ambulatory Blood Pressure Monitoring
Exclusion criteria
- mean seated systolic blood pressure equal or more than 200 mmHg and/or mean seated diastolic blood pressure equal or more than 120 mmHg
- any clinically significant hepatic impairment
- severe renal impairment
- bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post-renal transplant
- current treatment with any antihypertensive agents, whether or not prescribed for this indication, that cannot be safely stopped
- other conditions or situations that could put potential participants at unacceptable risk due to participation in this study
Data sourced from ClinicalTrials.gov (NCT01204398). 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.