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
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01103960
First received: April 13, 2010
Last updated: January 17, 2013
Last verified: January 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Telmisartan80mg+Amlodipine5mg Drug: amlodipine 5mg Drug: Telmisartan80mg+Amlodipine 5mg |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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 |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- Change From Baseline in DBP After 8 Weeks of Treatment [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]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:
- Change From Baseline in SBP After 8 Weeks of Treatment [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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.
| Enrollment: | 324 |
| Study Start Date: | July 2010 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- diagnosis of essential hypertension
- failure to respond adequately to six weeks treatment with amlodipine 5 mg monotherapy
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01103960
Locations
| 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 | |
| 1235.29.86010 Boehringer Ingelheim Investigational Site | |
| Shanghai, China | |
| 1235.29.86002 Boehringer Ingelheim Investigational Site | |
| Shanghai, China | |
| 1235.29.86009 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 Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01103960 History of Changes |
| Other Study ID Numbers: | 1235.29 |
| Study First Received: | April 13, 2010 |
| Results First Received: | August 21, 2012 |
| Last Updated: | January 17, 2013 |
| Health Authority: | China: Food and Drug Administration Malaysia: Ministry of Health Philippines: Bureau of Food and Drugs |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Amlodipine Telmisartan Benzoates Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents |
Therapeutic Uses Vasodilator Agents Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Antifungal Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on June 18, 2013