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
- Conditions
- Hypertension
- Interventions
- Registration Number
- NCT01103960
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 324
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telmisartan80mg+Amlodipine5mg Telmisartan80mg+Amlodipine5mg combination therapy amlodipine 5 mg Telmisartan80mg+Amlodipine 5mg Monotherapy amlodipine 5 mg amlodipine 5mg Monotherapy
- Primary Outcome Measures
Name Time Method Change From Baseline in DBP After 8 Weeks of Treatment Baseline and 8 weeks Seated trough DBP after 8 weeks or last observation carried forward (LOCF). Analysis will be adjusted for treatment, country, and baseline measurement of endpoint.
Change From Baseline in DBP After 8 Weeks of Treatment in Chinese Patients Baseline and 8 weeks Seated trough DBP after 8 weeks or LOCF in Chinese patients. Analysis will be adjusted for treatment and baseline measurement of endpoint.
- Secondary Outcome Measures
Name Time Method Change From Baseline in DBP After 4 Weeks of Treatment Baseline and 4 weeks Seated trough DBP after 4 weeks.
Change From Baseline in SBP After 8 Weeks of Treatment Baseline and 8 weeks Seated trough SBP after 8 weeks or LOCF. Analysis will be adjusted for treatment, country, and baseline measurement of endpoint.
DBP and SBP Control and Response After 8 Weeks of Treatment Baseline and 8 weeks DBP control is defined as DBP \<90 mmHg or \<80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP \<140 mmHg or \<130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP \<90 mmHg or \<80 mmHg in patients with diabetes or renal impairment or a reduction from baseline \>=10mmHg. SBP response is defined as SBP\<140 mmHg or \<130 mmHg in patients with diabetes or renal impairment or a reduction from baseline \>=15mmHg.
Number of Patients in Blood Pressure Categories Over Time 8 weeks BP optimal: SBP \<120 mmHg and DBP \<80 mmHg, BP normal: SBP \<130 mmHg and DBP \<85 mmHg but not optimal, BP high-normal: SBP \<140 mmHg and DBP \<90 mmHg but not normal. Grade 1 hypertension: SBP \<160 mmHg and DBP \<100 mmHg but not high-normal, Grade 2 hypertension: SBP \<180 mmHg and DBP \<110 mmHg but not grade 1, Grade 3 hypertension: SBP \>=180 mmHg or DBP \>=110 mmHg.
Change From Baseline in SBP After 4 Weeks of Treatment Baseline and 4 weeks Seated trough SBP after 4 weeks.
DBP and SBP Control and Response After 4 Weeks of Treatment Baseline and 4 weeks DBP control is defined as DBP \<90 mmHg or \<80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP \<140 mmHg or \<130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP \<90 mmHg or \<80 mmHg in patients with diabetes or renal impairment or a reduction from baseline \>=10mmHg. SBP response is defined as SBP\<140 mmHg or \<130 mmHg in patients with diabetes or renal impairment or a reduction from baseline \>=15mmHg.
Number of Patients in Blood Pressure Categories at 4 Weeks 4 weeks BP optimal: SBP \<120 mmHg and DBP \<80 mmHg, BP normal: SBP \<130 mmHg and DBP \<85 mmHg but not optimal, BP high-normal: SBP \<140 mmHg and DBP \<90 mmHg but not normal. Grade 1 hypertension: SBP \<160 mmHg and DBP \<100 mmHg but not high-normal, Grade 2 hypertension: SBP \<180 mmHg and DBP \<110 mmHg but not grade 1, Grade 3 hypertension: SBP \>=180 mmHg or DBP \>=110 mmHg.
Clinically Relevant Abnormalities for Physical Examination, Pulse Rate, Laboratory Parameters and ECG. From drug administration until end of treatment plus one day Clinically relevant abnormalities for Physical examination, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.
Trial Locations
- Locations (16)
1235.29.86002 Boehringer Ingelheim Investigational Site
🇨🇳Shanghai, China
1235.29.63018 Boehringer Ingelheim Investigational Site
🇵ðŸ‡Metro Manila, Philippines
1235.29.86001 Boehringer Ingelheim Investigational Site
🇨🇳Beijing, China
1235.29.86009 Boehringer Ingelheim Investigational Site
🇨🇳Shanghai, China
1235.29.86010 Boehringer Ingelheim Investigational Site
🇨🇳Shanghai, China
1235.29.86011 Boehringer Ingelheim Investigational Site
🇨🇳Shanghai, China
1235.29.86008 Boehringer Ingelheim Investigational Site
🇨🇳Tianjin, China
1235.29.60016 Boehringer Ingelheim Investigational Site
🇲🇾Kuala Lumpur, Malaysia
1235.29.86004 Boehringer Ingelheim Investigational Site
🇨🇳Beijing, China
1235.29.86006 Boehringer Ingelheim Investigational Site
🇨🇳Changchun, China
1235.29.86013 Boehringer Ingelheim Investigational Site
🇨🇳Changsha, China
1235.29.86012 Boehringer Ingelheim Investigational Site
🇨🇳Hangzhou, China
1235.29.86014 Boehringer Ingelheim Investigational Site
🇨🇳Guangzhou, China
1235.29.86007 Boehringer Ingelheim Investigational Site
🇨🇳Shenyang, China
1235.29.63019 Boehringer Ingelheim Investigational Site
🇵ðŸ‡Quezon City, Philippines
1235.29.60017 Boehringer Ingelheim Investigational Site
🇲🇾Johor, Malaysia