Clinical trial NCT01103960: An Eight-week Randomized,Double-blind Study to Evaluate the Efficacy and Safety of Fixed-dose Combinations of T80+A5 Versus A5 Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With A5 Monotherapy
Official title: 8 Week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80mg+ Amlodipine 5 mg vs. Amlodipine 5mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 5mg Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-04-15
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objectives of this trial is to demonstrate that the fixed-dose combination of telmisartan 80mg plus amlodipine 5mg (T80/A5) is superior to amlodipine 5mg (A5) in reducing seated trough diastolic blood pressure (DBP) at 8 weeks.


Eligibility criteria: Inclusion criteria:

1. diagnosis of essential hypertension
2. failure to respond adequately to six weeks treatment with amlodipine 5 mg monotherapy
3. provision of written informed consent

Exclusion criteria:

1. clinical conditions which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine for the planned duration of this trial (e.g. populations where labeling of either product recommends against its utilization)

Primary outcomes:
measure: Change From Baseline in DBP After 8 Weeks of Treatment
timeFrame: Baseline and 8 weeks
measure: Change From Baseline in DBP After 8 Weeks of Treatment in Chinese Patients
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Change From Baseline in SBP After 8 Weeks of Treatment
timeFrame: Baseline and 8 weeks
measure: DBP and SBP Control and Response After 8 Weeks of Treatment
timeFrame: Baseline and 8 weeks
measure: Number of Patients in Blood Pressure Categories Over Time
timeFrame: 8 weeks
measure: Change From Baseline in DBP After 4 Weeks of Treatment
timeFrame: Baseline and 4 weeks
measure: Change From Baseline in SBP After 4 Weeks of Treatment
timeFrame: Baseline and 4 weeks
measure: DBP and SBP Control and Response After 4 Weeks of Treatment
timeFrame: Baseline and 4 weeks
measure: Number of Patients in Blood Pressure Categories at 4 Weeks
timeFrame: 4 weeks
measure: Clinically Relevant Abnormalities for Physical Examination, Pulse Rate, Laboratory Parameters and ECG.
timeFrame: From drug administration until end of treatment plus one day
Other outcomes:
Locations:
city: Beijing
country: China
facility: 1235.29.86001 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 1235.29.86004 Boehringer Ingelheim Investigational Site
city: Changchun
country: China
facility: 1235.29.86006 Boehringer Ingelheim Investigational Site
city: Changsha
country: China
facility: 1235.29.86013 Boehringer Ingelheim Investigational Site
city: Guangzhou
country: China
facility: 1235.29.86014 Boehringer Ingelheim Investigational Site
city: Hangzhou
country: China
facility: 1235.29.86012 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 1235.29.86002 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 1235.29.86009 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 1235.29.86010 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 1235.29.86011 Boehringer Ingelheim Investigational Site
city: Shenyang
country: China
facility: 1235.29.86007 Boehringer Ingelheim Investigational Site
city: Tianjin
country: China
facility: 1235.29.86008 Boehringer Ingelheim Investigational Site
city: Johor
country: Malaysia
facility: 1235.29.60017 Boehringer Ingelheim Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: 1235.29.60016 Boehringer Ingelheim Investigational Site
city: Metro Manila
country: Philippines
facility: 1235.29.63018 Boehringer Ingelheim Investigational Site
city: Quezon City
country: Philippines
facility: 1235.29.63019 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Zhu D, Gao P, Holtbruegge W, Huang C. A randomized, double-blind study to evaluate the efficacy and safety of a single-pill combination of telmisartan 80 mg/amlodipine 5 mg versus amlodipine 5 mg in hypertensive Asian patients. J Int Med Res. 2014 Feb;42(1):52-66. doi: 10.1177/0300060513503756. Epub 2014 Jan 3.