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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00926289
First received: June 22, 2009
Last updated: June 17, 2014
Last verified: December 2013
  Purpose

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).


Condition Intervention Phase
Hypertension
Drug: Telmisartan
Drug: Hydrochlorothiazide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change From Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) to Week 7 [ Time Frame: Baseline and Week 7 ] [ Designated as safety issue: No ]
    The SBP value at baseline was subtracted from the SBP value at Week 7.


Secondary Outcome Measures:
  • Change From Baseline in Mean Seated Trough Cuff SBP to Week 5 [ Time Frame: Baseline and Week 5 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    DBP control is defined as DBP<90 mmHg

  • Number of Patients With Blood Pressure (BP) Control at Week 7 [ Time Frame: Week 7 timepoint ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    DBP response is defined as DBP<90 mmHg or a reduction of >= 10 mmHg

  • BP Categories at Week 7 [ Time Frame: Week 7 timepoint ] [ Designated as safety issue: No ]

    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)


Enrollment: 894
Study Start Date: June 2009
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Telmisartan
Telmisartan 80 mg
Drug: Telmisartan
Telmisartan 80mg
Experimental: Telmisartan/hydrochlorothiazide
Telmisartan80mg/Hydrochlorothiazide25mg
Drug: Telmisartan
Telmisartan 80mg
Drug: Hydrochlorothiazide
Hydrochlorothiazide25mg

  Eligibility

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

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
  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: NCT00926289

  Show 106 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00926289     History of Changes
Other Study ID Numbers: 502.550, 2008-007711-32
Study First Received: June 22, 2009
Results First Received: April 20, 2011
Last Updated: June 17, 2014
Health Authority: Bulgaria: Bulgarian Drug Agency
China: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Georgia: Ministry of Health
Korea: Food and Drug Administration
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Hydrochlorothiazide
Telmisartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Cardiovascular Agents
Diuretics
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014