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Telmisartan+Amlodipine Fixed Dose Combination in Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01204398
First received: September 16, 2010
Last updated: August 27, 2012
Last verified: August 2012
History of Changes
  Purpose

The primary objectives of this trial is to evaluate the changes from baseline (Visit 2) in the 24-hour Ambulatory Blood Pressure Monitoring mean (relative to dose time) for diastolic blood pressure and systolic blood pressure after 8 weeks of treatment with Telmisartan 80mg/Amlodipine 5mg in patients with moderate to severe hypertension


Condition Intervention Phase
Hypertension
 Drug: telmisartan+amlodipine fixed dose combination
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Study to Evaluate the Antihypertensive Effects of the Fixed-dose Combination of Telmisartan 80 mg and Amlodipine 5 mg (T80/A5) Given Once Daily by 24 h ABPM in Patients With Moderate to Severe Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • DBP and SBP Change From Baseline in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    ABPM measurements were taken every 20 minutes throughout the day and night by the validated SpaceLabs Model 90217 monitor.


Secondary Outcome Measures:
  • Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Changes from baseline in DBP and SBP hourly means over the 24-hour dosing interval as measured by ABPM after 8 weeks of treatment with T80/A5

  • Trough to Peak (T/P) Ratio for DBP and SBP After 8 Weeks of Treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Calculated on the basis of changes in hourly means from baseline. Trough is defined as the mean of the last three hours of the 24-hour dosing interval. Peak is the greatest reduction in hourly means in hours 2 to 8 after dosing. All measurements are using ABPM.

  • Change From Baseline to End of Study in DBP and SBP [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Manually measured in-clinic DBP and SBP

  • ABPM Hourly Mean DBP and SBP at the End of the Study, Starting 1 Hour After Dosing [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    DBP and SBP hourly means over the 24-hour dosing interval as measured by ABPM after 8 weeks of treatment

  • Treatment Emergent Adverse Events [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Electrocardiogram and physical examinations were performed and any abnormal findings were recorded within the adverse events

  • Change From Baseline to End of Study in In-clinic Pulse Rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: November 2010
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: eligible hypertension patient
Patients will be given placebo for 2 weeks for wash-out, then qualified patients will be administered Telmisartan 80mg/Amlodipine 5mg for 8 weeks.
 Drug: telmisartan+amlodipine fixed dose combination
after 2 weeks placebo wash-out, patients will be administered Telmisartan 80mg/Amlodipine 5mg for 8 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Aged at least 18 years at the date of signing the consent form
  2. For treatment-naïve patients: hypertension defined by a mean seated diastolic blood pressure (DBP) equal or more than 100 mmHg measured by manual cuff sphygmomanometry at visit 1 and 2; For pretreatment patients: hypertension defined by a mean seated diastolic blood pressure equal or more than 90 mmHg at visit 1 and equal or more than 100 mmHg at visit 2 measured by manual cuff sphygmomanometry
  3. 24-hour mean diastolic blood pressure equal or more than 85 mmHg at baseline Ambulatory Blood Pressure Monitoring

Exclusion criteria:

  1. mean seated systolic blood pressure equal or more than 200 mmHg and/or mean seated diastolic blood pressure equal or more than 120 mmHg
  2. any clinically significant hepatic impairment
  3. severe renal impairment
  4. bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post-renal transplant
  5. current treatment with any antihypertensive agents, whether or not prescribed for this indication, that cannot be safely stopped
  6. other conditions or situations that could put potential participants at unacceptable risk due to participation in this study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01204398

Locations
China
1235.31.86001 Boehringer Ingelheim Investigational Site
Shanghai, China
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01204398     History of Changes
Other Study ID Numbers: 1235.31
Study First Received: September 16, 2010
Results First Received: July 20, 2012
Last Updated: August 27, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Amlodipine
Telmisartan
Benzoates
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator 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 May 19, 2013