Open Label Study Telmisartan and Amlodipine in Hypertension

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00614380
First received: January 28, 2008
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40 mg / amlodipine 5 mg (T40/A5) or telmisartan 80 mg / amlodipine 5 mg (T80/A5) during long-term open-label treatment.


Condition Intervention Phase
Hypertension
Drug: telmisartan/amlodipine 40/5 mg fixed combination
Drug: telmisartan/amlodipine 80/5 mg fixed combination
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
Official Title: An Open Label Follow-up Trial of the Efficacy and Safety of Chronic Administration of the Combination of Telmisartan 40mg + Amlodipine 5mg or the Combination of Telmisartan 80mg + Amlodipine 5mg Tablets Alone or in Combination With Other Antihypertensive Medications in Patients With Hypertension.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Trough Seated Diastolic Blood Pressure (DBP) Control [ Time Frame: End of study (34 weeks or last value on treatment) ] [ Designated as safety issue: No ]
    The number of patients who reach the target DBP of <90mmHg


Secondary Outcome Measures:
  • Trough Seated Systolic Blood Pressure (SBP) Control [ Time Frame: End of study (34 weeks or last value on treatment) ] [ Designated as safety issue: No ]
    The number of patients who reach the target SBP of <140mmHg

  • Change From Baseline in Trough Seated Diastolic Blood Pressure [ Time Frame: End of study (34 weeks or last value on treatment) ] [ Designated as safety issue: No ]
    Change from baseline to the end of study in trough DBP. Baseline is defined as visit 3 of trial 1235.5.

  • Change in DBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7 [ Time Frame: End of study (34 weeks or last value on treatment) ] [ Designated as safety issue: No ]
    The difference between the last available troughs represents the additional reduction in DBP in this study

  • Change From Baseline in Trough Seated Systolic Blood Pressure [ Time Frame: End of study (34 weeks or last value on treatment) ] [ Designated as safety issue: No ]
    Change from baseline to the end of study in trough SBP. Baseline is defined as visit 3 of trial 1235.5.

  • Change in SBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7 [ Time Frame: End of study (34 weeks or last value on treatment) ] [ Designated as safety issue: No ]
    The difference between the last available troughs represents the additional reduction in SBP in this study

  • Trough Seated DBP Response [ Time Frame: End of study (34 weeks or last value on treatment) ] [ Designated as safety issue: No ]
    The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg

  • Trough Seated SBP Response [ Time Frame: End of study (34 weeks or last value on treatment) ] [ Designated as safety issue: No ]
    The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg

  • Trough Blood Pressure (BP) Normality Classes [ Time Frame: End of study (34 weeks or last value on treatment) ] [ Designated as safety issue: No ]
    The number of patients who reach predefined BP categories

  • Time to First Additional Antihypertensive [ Time Frame: At any point during open-label treatment ] [ Designated as safety issue: No ]
    Time from first intake of medication to first intake of an antihypertensive other than the study drug

  • Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control [ Time Frame: At any point during open-label treatment ] [ Designated as safety issue: No ]
    The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before taking additional antihypertensive compared to last trough DBP taken on treatment

  • Additional Reduction in DBP by Use of Additional Antihypertensive Therapy [ Time Frame: At any point during open-label treatment ] [ Designated as safety issue: No ]
    Difference in trough DBP from last visit before add-on therapy and last visit during 1235.7

  • Additional Reduction in SBP by Use of Additional Antihypertensive Therapy [ Time Frame: At any point during open-label treatment ] [ Designated as safety issue: No ]
    Difference in trough SBP from last visit before add-on therapy and last visit during 1235.7

  • Trough DBP Control Pre- and Post- Uptitration [ Time Frame: At any point during open-label treatment ] [ Designated as safety issue: No ]
    The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before uptitration to Telmisartan 80mg compared to first trough DBP taken after uptitration


Enrollment: 976
Study Start Date: January 2008
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. patients aged at least 18 years
  2. diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the preceding trial.
  3. failure to respond to six weeks treatment with Amlodipine 5 mg in the run-in period of the preceding trial.

Exclusion Criteria:

  1. pre-menopausal women who are not surgically sterile; or are nursing or pregnant; or are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study
  2. development of any medical condition in the preceding trial that in the investigator's opinion could be worsened by treatment with either Telmisartan 40 mg/Amlodipine 5 mg or Telmisartan 80 mg/Amlodipine 5 mg
  3. discontinuation from the preceding trial because of any adverse event or any other reason
  4. known or suspected secondary hypertension
  5. mean seated Systolic Blood Pressure => 180 mmHg and/or mean seated Diastolic Blood Pressure => 120 mmHg at any visit
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614380

  Show 122 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00614380     History of Changes
Other Study ID Numbers: 1235.7, EUDRACT2007-002410-19
Study First Received: January 28, 2008
Results First Received: December 14, 2009
Last Updated: December 16, 2013
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Canada: Health Canada (TPD)
Denmark: Lægemiddelstyrelsen, Kliniske forsøg, Inspektionen Axel Heides Gade 1, DK-2300 Copenhagen S
Finland: Finnish Medicines Agency
France: AGENCE FRANCAISE DE SECURITE SANITAIRE DES PRODUITS DE SANTE
Korea, Republic of: Korea Food and Drug Administration (KFDA)
Netherlands: Central Committee on Research involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency (Statens Legemiddelverk)
Philippines: Department of Health, Republic of the Philippines
South Africa: Medicines Control Council
Sweden: Regional Ethics Committee of Stockholm, PO Box 289, SE-17177 Stockholm, Sweden. Medical Products Agency
Taiwan: Department of Health, Executive Yuan, Taiwan
United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Amlodipine
Antihypertensive Agents
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

ClinicalTrials.gov processed this record on September 18, 2014