Full Text View
Tabular View
No Study Results Posted
Related Studies
T+H25 First Line in Severe HTN
This study is currently recruiting participants.
Verified by Boehringer Ingelheim Pharmaceuticals, August 2009
First Received: June 22, 2009   Last Updated: August 20, 2009   History of Changes
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00926289
  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 SBP compared to the monotherapy of T80 in patients with severe hypertension.


Condition Intervention Phase
Hypertension
Drug: Telmisartan80mg
Drug: Telmisartan80mg/hydrochlorothiazide25mg
Phase IV

Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomised, Double-blind, Controlled, Parallel Group Study to Compare the Fixed-dose Combination of Telmisartan 80mg Plus Hydrochlorothiazide 25mg (T80/H25) Versus Telmisartan 80mg (T80) Monotherapy as First Line Therapy in Patients With Severe Hypertension (Grade 3).

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 840
Study Start Date: June 2009
Estimated Primary Completion Date: June 2010 (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. Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation;
  2. Age 18 years or older;
  3. Patients with severe hypertension as defined SBP>=180 mmHg and DBP>=95 mmHg at randomisation;
  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 NYHA functional class CHF 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 runin 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 HbA1C>=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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00926289

Contacts
Contact: Boehringer Ingelheim Study Coordinator 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

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

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 502.550, Eudra CT: 2008-007711-32
Study First Received: June 22, 2009
Last Updated: August 20, 2009
ClinicalTrials.gov Identifier: NCT00926289     History of Changes
Health Authority: Bulgaria: Bulgarian Drug Agency;   China: State Food and Drug Administration;   France: Afssaps - French Health Products Safety Agency;   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

Study placed in the following topic categories:
Anti-Infective Agents
Benzoates
Diuretics
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Angiotensin II
Hydrochlorothiazide
Protease Inhibitors
Angiotensin II Type 1 Receptor Blockers
Antifungal Agents
Angiotensin-Converting Enzyme Inhibitors
Telmisartan
Hypertension

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

ClinicalTrials.gov processed this record on September 09, 2009