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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

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ClinicalTrials.gov Identifier: NCT01103960
Recruitment Status : Completed
First Posted : April 15, 2010
Results First Posted : September 20, 2012
Last Update Posted : June 27, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Telmisartan80mg+Amlodipine5mg Drug: amlodipine 5mg Drug: Telmisartan80mg+Amlodipine 5mg Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : July 2010
Actual Primary Completion Date : August 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Telmisartan80mg+Amlodipine5mg
combination therapy
 Drug: Telmisartan80mg+Amlodipine5mg
combination therapy
Active Comparator: amlodipine 5 mg
Monotherapy
 Drug: amlodipine 5mg
monotherapy

Drug: Telmisartan80mg+Amlodipine 5mg
combination therapy


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in DBP After 8 Weeks of Treatment [ Time Frame: 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.

  2. Change From Baseline in DBP After 8 Weeks of Treatment in Chinese Patients [ Time Frame: 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 :
  1. Change From Baseline in SBP After 8 Weeks of Treatment [ Time Frame: Baseline and 8 weeks ]
    Seated trough SBP after 8 weeks or LOCF. Analysis will be adjusted for treatment, country, and baseline measurement of endpoint.

  2. DBP and SBP Control and Response After 8 Weeks of Treatment [ Time Frame: 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.

  3. Number of Patients in Blood Pressure Categories Over Time [ Time Frame: 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.

  4. Change From Baseline in DBP After 4 Weeks of Treatment [ Time Frame: Baseline and 4 weeks ]
    Seated trough DBP after 4 weeks.

  5. Change From Baseline in SBP After 4 Weeks of Treatment [ Time Frame: Baseline and 4 weeks ]
    Seated trough SBP after 4 weeks.

  6. DBP and SBP Control and Response After 4 Weeks of Treatment [ Time Frame: 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.

  7. Number of Patients in Blood Pressure Categories at 4 Weeks [ Time Frame: 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.

  8. Clinically Relevant Abnormalities for Physical Examination, Pulse Rate, Laboratory Parameters and ECG. [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01103960


Locations
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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, China
Malaysia
1235.29.60017 Boehringer Ingelheim Investigational Site
Johor, Malaysia
1235.29.60016 Boehringer Ingelheim Investigational Site
Kuala Lumpur, Malaysia
Philippines
1235.29.63018 Boehringer Ingelheim Investigational Site
Metro Manila, Philippines
1235.29.63019 Boehringer Ingelheim Investigational Site
Quezon City, Philippines
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01103960    
Other Study ID Numbers: 1235.29
First Posted: April 15, 2010    Key Record Dates
Results First Posted: September 20, 2012
Last Update Posted: June 27, 2014
Last Verified: December 2013
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Telmisartan
Antihypertensive Agents
Calcium Channel Blockers
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists