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Telmisartan 80mg Plus Hydrochlorothiazide 25mg First Line in Moderate or Severe Hypertension

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ClinicalTrials.gov Identifier: NCT00926289
Recruitment Status : Completed
First Posted : June 23, 2009
Results First Posted : May 24, 2011
Last Update Posted : June 27, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE June 22, 2009
First Posted Date  ICMJE June 23, 2009
Results First Submitted Date  ICMJE April 20, 2011
Results First Posted Date  ICMJE May 24, 2011
Last Update Posted Date June 27, 2014
Study Start Date  ICMJE June 2009
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2011)
Change From Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) to Week 7 [ Time Frame: Baseline and Week 7 ]
The SBP value at baseline was subtracted from the SBP value at Week 7.
Original Primary Outcome Measures  ICMJE
 (submitted: June 22, 2009)
The primary objective of this trial is to demonstrate that the fixed dose combination of T80/HCTZ25 is superior as first line therapy in reducing seated trough cuff SBP compared to the monotherapy of T80 in patients with severe hypertension. [ Time Frame: 10 weeks ]
Change History Complete list of historical versions of study NCT00926289 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2011)
  • Change From Baseline in Mean Seated Trough Cuff SBP to Week 5 [ Time Frame: Baseline and Week 5 ]
    The SBP value at baseline was subtracted from the SBP value at Week 5.
  • Change From Baseline in Mean Seated Trough Cuff SBP to Week 3 [ Time Frame: Baseline and Week 3 ]
    The SBP value at baseline was subtracted from the SBP value at Week 3.
  • Change From Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) to Week 7 [ Time Frame: Baseline and Week 7 ]
    The DBP value at baseline was subtracted from the DBP value at Week 7.
  • Number of Patients With SBP Control (SBP < 140 mmHg) at Week 7 [ Time Frame: Week 7 timepoint ]
    SBP control is defined as SBP < 140 mmHg.
  • Number of Patients With SBP Control (SBP < 140 mmHg) at Week 5 [ Time Frame: Week 5 timepoint ]
    SBP control is defined as SBP < 140 mmHg
  • Number of Patients With SBP Control (SBP < 140 mmHg) at Week 3 [ Time Frame: Week 3 timepoint ]
    SBP control is defined as SBP < 140 mmHg
  • Number of Patients With DBP Control (DBP < 90 mmHg) at Week 7 [ Time Frame: Week 7 timepoint ]
    DBP control is defined as DBP<90 mmHg
  • Number of Patients With DBP Control (DBP < 90 mmHg) at Week 5 [ Time Frame: Week 5 timepoint ]
    DBP control is defined as DBP<90 mmHg
  • Number of Patients With DBP Control (DBP < 90 mmHg) at Week 3 [ Time Frame: Week 3 timepoint ]
    DBP control is defined as DBP<90 mmHg
  • Number of Patients With Blood Pressure (BP) Control at Week 7 [ Time Frame: Week 7 timepoint ]
    BP control is defined as SBP<140 mmHg and DBP < 90 mmHg and is adjusted for baseline SBP
  • Number of Patients With BP Control at Week 7 [ Time Frame: Week 7 timepoint ]
    BP control is defined as SBP<140 mmHg and DBP < 90 mmHg and is adjusted for baseline DBP
  • Number of Patients With Systolic Blood Pressure (SBP) Response at Week 7 [ Time Frame: Week 7 timepoint ]
    SBP response is defined as SBP<140 mmHg or a reduction of >= 15 mmHg
  • Number of Participants With DBP Response at Week 7 [ Time Frame: Week 7 timepoint ]
    DBP response is defined as DBP<90 mmHg or a reduction of >= 10 mmHg
  • BP Categories at Week 7 [ Time Frame: Week 7 timepoint ]
    BP categories comprise:
    • 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 hypertension')
    • Grade 3 hypertension (SBP ≥180 mmHg or DBP ≥110 mmHg)
Original Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2009)
Change from baseline in mean seated trough cuff systolic blood pressure SBP control rate (SBP<140 mmHg) at final visit (w7) and at w5, w3 Change from baseline in mean seated DBP (trough cuff) to final visit (w7); DBP control rate [ Time Frame: 10 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Telmisartan 80mg Plus Hydrochlorothiazide 25mg First Line in Moderate or Severe Hypertension
Official Title  ICMJE A Randomised, Double-blind, Double Dummy, Active Controlled, Parallel Group, Forced Titration Study to Compare the Fixed-dose Combination of Telmisartan 80mg Plus Hydrochlorothiazide 25mg (T80/HCTZ25) Versus Telmisartan 80mg (T80) Monotherapy as First Line Therapy in Patients With Grade 2 or Grade 3 Hypertension (Systolic Blood Pressure (SBP) >=160 mmHg and Diastolic Blood Pressure (DBP) >=100 mmHg)
Brief Summary The primary objective of this trial is to demonstrate that the fixed-dose combination of T80/HCTZ25 is superior as first line therapy in reducing seated trough cuff Systolic Blood Pressure(SBP) compared to the monotherapy of T80 in patients with grade 2 or grade 3 hypertension (SBP>=160 mmHg and Diastolic Blood Pressure(DBP)>=100 mmHg).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: Telmisartan
    Telmisartan 80mg
  • Drug: Hydrochlorothiazide
    Hydrochlorothiazide25mg
Study Arms  ICMJE
  • Active Comparator: Telmisartan
    Telmisartan 80 mg
    Intervention: Drug: Telmisartan
  • Experimental: Telmisartan/hydrochlorothiazide
    Telmisartan80mg/Hydrochlorothiazide25mg
    Interventions:
    • Drug: Telmisartan
    • Drug: Hydrochlorothiazide
Publications * Zhu DL, Bays H, Gao P, Mattheus M, Voelker B, Ruilope LM. Efficacy and tolerability of initial therapy with single-pill combination telmisartan/hydrochlorothiazide 80/25 mg in patients with grade 2 or 3 hypertension: a multinational, randomized, double-blind, active-controlled trial. Clin Ther. 2012 Jul;34(7):1613-24. doi: 10.1016/j.clinthera.2012.05.007. Epub 2012 Jun 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 14, 2010)
894
Original Estimated Enrollment  ICMJE
 (submitted: June 22, 2009)
840
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation;
  2. Age 18 years or older;
  3. Patients with grade 2 or grade 3 hypertension as defined SBP>=160 mmHg and DBP>=100 mmHg at randomization
  4. Ability to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigator's discretion)

Exclusion criteria:

  1. Pre-menopausal women (last menstruation <=1 year prior to signing informed consent) who: a) are not surgically sterile; or b) are nursing, or c) are pregnant, or d) are of childbearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the trial. The only acceptable methods of birth control are: Intra-Uterine Device (IUD), Oral contraceptives, Implantable or injectable contraceptives, Estrogen patch Hormonal birth control should have been in use for at least three months before the study and continue at least until the next menstrual period after completing the study.
  2. Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 a.m.
  3. Known or suspected secondary hypertension (e.g., renal artery stenosis orphaeochromocytoma)
  4. Mean in-clinic seated cuff SBP>= 200 mmHg and/or DBP >=120 mmHg
  5. Renal dysfunction as defined by the following laboratory parameters: Serum creatinine >3.0 mg/dL (or >265 umol/L) and/or known creatinine clearance of <30 ml/min and/or clinical markers of severe renal impairment.
  6. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney
  7. Clinically relevant hypokalemia or hyperkalemia (i.e., <3.5 mmol/L or >5.5 mmol/L, may be rechecked for suspected error in result)
  8. Uncorrected sodium or volume depletion
  9. Primary aldosteronism.
  10. Hereditary fructose intolerance
  11. Biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency
  12. Congestive heart failure New York Heart Association functional class Congestive Heart Failure III-IV (Refer to Appendix 10.3)
  13. Contra-indication to a placebo run-in period (e.g., stroke with-in the past 6 months, myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past 3 months prior to start of run in period)
  14. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the Investigator
  15. Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
  16. Patients whose diabetes has not been stable and controlled for at least the past 3 months as defined by an Glycosylated Hemoglobin >=10%
  17. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists
  18. History of drug or alcohol dependency within 6 months prior to signing the informed consent form
  19. Concomitant administration of any medications known to affect blood pressure, except medications allowed by the protocol
  20. Any investigational drug therapy within 1 month of signing the informed consent
  21. Known hypersensitivity to any component of the trial drugs (telmisartan, hydrochlorothiazide, or placebo)
  22. History of non-compliance or inability to comply with prescribed medications or protocol procedures (less than 80% or more than 120%, especially during run-in)
  23. Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   China,   France,   Georgia,   Korea, Republic of,   Romania,   Russian Federation,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00926289
Other Study ID Numbers  ICMJE 502.550
2008-007711-32 ( EudraCT Number: EudraCT )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date December 2013

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