Clinical trial NCT01204398: Telmisartan+Amlodipine Fixed Dose Combination in Hypertension
Official title: An Open-label Study to Evaluate the Antihypertensive Effects of the Fixed-dose Combination of Telmisartan 80 mg and Amlodipine 5 mg (T80/A5) Given Once Daily by 24 h ABPM in Patients With Moderate to Severe Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-09-17
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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:

1. Aged at least 18 years at the date of signing the consent form
2. 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
3. 24-hour mean diastolic blood pressure equal or more than 85 mmHg at baseline Ambulatory Blood Pressure Monitoring

Exclusion criteria:

1. mean seated systolic blood pressure equal or more than 200 mmHg and/or mean seated diastolic blood pressure equal or more than 120 mmHg
2. any clinically significant hepatic impairment
3. severe renal impairment
4. bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post-renal transplant
5. current treatment with any antihypertensive agents, whether or not prescribed for this indication, that cannot be safely stopped
6. other conditions or situations that could put potential participants at unacceptable risk due to participation in this study

Primary outcomes:
measure: DBP and SBP Change From Baseline in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean
timeFrame: 8 weeks
Secondary outcomes:
measure: Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
timeFrame: 8 weeks
measure: Trough to Peak (T/P) Ratio for DBP and SBP After 8 Weeks of Treatment
timeFrame: 8 weeks
measure: Change From Baseline to End of Study in DBP and SBP
timeFrame: 8 weeks
measure: ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
timeFrame: 0 and 8 weeks
measure: Treatment Emergent Adverse Events
timeFrame: 8 weeks
measure: Change From Baseline to End of Study in In-clinic Pulse Rate
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 1235.31.86001 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: