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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01103960
• Other study ID #: 1235.29
• Status: Completed
• Phase: Phase 3
• First received: April 13, 2010
• Last updated: June 17, 2014
• Start date: July 2010

Study information

• Verified date: December 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationMalaysia: Ministry of HealthPhilippines: Bureau of Food and Drugs
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Telmisartan80mg+Amlodipine5mg
combination therapy
• amlodipine 5mg
monotherapy
• Telmisartan80mg+Amlodipine 5mg
combination therapy

Locations

Country	Name	City	State
China	1235.29.86001 Boehringer Ingelheim Investigational Site	Beijing
China	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	1235.29.86014 Boehringer Ingelheim Investigational Site	Guangzhou
China	1235.29.86012 Boehringer Ingelheim Investigational Site	Hangzhou
China	1235.29.86002 Boehringer Ingelheim Investigational Site	Shanghai
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	1235.29.86007 Boehringer Ingelheim Investigational Site	Shenyang
China	1235.29.86008 Boehringer Ingelheim Investigational Site	Tianjin
Malaysia	1235.29.60017 Boehringer Ingelheim Investigational Site	Johor
Malaysia	1235.29.60016 Boehringer Ingelheim Investigational Site	Kuala Lumpur
Philippines	1235.29.63018 Boehringer Ingelheim Investigational Site	Metro Manila
Philippines	1235.29.63019 Boehringer Ingelheim Investigational Site	Quezon City

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

China,  Malaysia,  Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in DBP After 8 Weeks of Treatment	Seated trough DBP after 8 weeks or last observation carried forward (LOCF). Analysis will be adjusted for treatment, country, and baseline measurement of endpoint.	Baseline and 8 weeks	No
Primary	Change From Baseline in DBP After 8 Weeks of Treatment in Chinese Patients	Seated trough DBP after 8 weeks or LOCF in Chinese patients. Analysis will be adjusted for treatment and baseline measurement of endpoint.	Baseline and 8 weeks	No
Secondary	Change From Baseline in SBP After 8 Weeks of Treatment	Seated trough SBP after 8 weeks or LOCF. Analysis will be adjusted for treatment, country, and baseline measurement of endpoint.	Baseline and 8 weeks	No
Secondary	DBP and SBP Control and Response After 8 Weeks of Treatment	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.	Baseline and 8 weeks	No
Secondary	Number of Patients in Blood Pressure Categories Over Time	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.	8 weeks	No
Secondary	Change From Baseline in DBP After 4 Weeks of Treatment	Seated trough DBP after 4 weeks.	Baseline and 4 weeks	No
Secondary	Change From Baseline in SBP After 4 Weeks of Treatment	Seated trough SBP after 4 weeks.	Baseline and 4 weeks	No
Secondary	DBP and SBP Control and Response After 4 Weeks of Treatment	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.	Baseline and 4 weeks	No
Secondary	Number of Patients in Blood Pressure Categories at 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.	4 weeks	No
Secondary	Clinically Relevant Abnormalities for Physical Examination, Pulse Rate, Laboratory Parameters and ECG.	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.	From drug administration until end of treatment plus one day	No

External Links

•   Link