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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

January 28, 2008
December 16, 2013
January 2008
March 2009   (final data collection date for primary outcome measure)
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
The primary endpoit is the proportion of patients achieving DBP control
Complete list of historical versions of study NCT00614380 on ClinicalTrials.gov Archive Site
  • 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
change from baseline in seated through DBP change frmo baseline in seated SBP proportion of patients achieving DBP response proportion of patients achieving SBP response
Not Provided
Not Provided
 
Open Label Study Telmisartan and Amlodipine in Hypertension
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.

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
Hypertension
  • Drug: telmisartan/amlodipine 40/5 mg fixed combination
  • Drug: telmisartan/amlodipine 80/5 mg fixed combination
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
976
Not Provided
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   Denmark,   Finland,   France,   Korea, Republic of,   Netherlands,   Norway,   Philippines,   South Africa,   Sweden,   Taiwan
 
NCT00614380
1235.7, EUDRACT2007-002410-19
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP