T+H25 First Line in Morderate or Severe HTN

Condition(s) targeted: Hypertension

Intervention: Telmisartan80mg (Drug); Telmisartan80mg/hydrochlorothiazide25mg (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Boehringer Ingelheim Pharmaceuticals

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim Pharmaceuticals

Overall contact:
Boehringer Ingelheim Study Coordinator, Phone: 1-800-243-0127, Email: clintriage.rdg@boehringer-ingelheim.com

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 grade 2 or grade 3 hypertension (SBP>=160 mmHg and DBP>=100 mmHg).

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 (SBP>=160 mmHg and DBP>=100 mmHg)

Study design: Treatment, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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.

Secondary outcome: 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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 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

Boehringer Ingelheim Study Coordinator, Phone: 1-800-243-0127, Email: clintriage.rdg@boehringer-ingelheim.com

502.550.35901 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria; Not yet recruiting

502.550.35902 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria; Not yet recruiting

502.550.35903 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria; Not yet recruiting

502.550.35904 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria; Not yet recruiting

502.550.35905 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria; Not yet recruiting

502.550.35906 Boehringer Ingelheim Investigational Site, Stara Zagora, Bulgaria; Not yet recruiting

502.550.35908 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria; Not yet recruiting

502.550.35909 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria; Not yet recruiting

502.550.35910 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria; Not yet recruiting

502.550.35911 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria; Not yet recruiting

502.550.3306F Boehringer Ingelheim Investigational Site, St Jouan des Guerets, France; Recruiting

502.550.3302C Boehringer Ingelheim Investigational Site, Donges, France; Recruiting

502.550.3302D Boehringer Ingelheim Investigational Site, Aigrefeuille S/Maine, France; Recruiting

502.550.3302E Boehringer Ingelheim Investigational Site, Nantes, France; Recruiting

502.550.3302G Boehringer Ingelheim Investigational Site, St Aubin les Châteaux, France; Recruiting

502.550.3302I Boehringer Ingelheim Investigational Site, Corsept, France; Recruiting

502.550.3303B Boehringer Ingelheim Investigational Site, Marseille, France; Not yet recruiting

502.550.3303C Boehringer Ingelheim Investigational Site, Roquevaire, France; Not yet recruiting

502.550.3303D Boehringer Ingelheim Investigational Site, Marseille, France; Not yet recruiting

502.550.3303F Boehringer Ingelheim Investigational Site, Marseille, France; Not yet recruiting

502.550.3305A Boehringer Ingelheim Investigational Site, Marseille, France; Not yet recruiting

502.550.3304B Boehringer Ingelheim Investigational Site, Marseille, France; Not yet recruiting

502.550.3304C Boehringer Ingelheim Investigational Site, Marseille, France; Not yet recruiting

502.550.3304D Boehringer Ingelheim Investigational Site, Marseille, France; Recruiting

502.550.3304I Boehringer Ingelheim Investigational Site, Marseille, France; Not yet recruiting

502.550.3304J Boehringer Ingelheim Investigational Site, Marseille, France; Not yet recruiting

502.550.3304K Boehringer Ingelheim Investigational Site, Marseille, France; Not yet recruiting

502.550.3305B Boehringer Ingelheim Investigational Site, Marseille, France; Not yet recruiting

502.550.3307A Boehringer Ingelheim Investigational Site, Thouars, France; Recruiting

502.550.3301E Boehringer Ingelheim Investigational Site, Parcay-les-Pins, France; Recruiting

502.550.3301F Boehringer Ingelheim Investigational Site, Segre, France; Recruiting

502.550.3301H Boehringer Ingelheim Investigational Site, Briollay, France; Recruiting

502.550.3301I Boehringer Ingelheim Investigational Site, Murs-Erigne, France; Recruiting

502.550.3301J Boehringer Ingelheim Investigational Site, Vihiers, France; Recruiting

502.550.3301K Boehringer Ingelheim Investigational Site, Cholet, France; Recruiting

502.550.3302B Boehringer Ingelheim Investigational Site, La Montagne, France; Recruiting

502.550.3301A Boehringer Ingelheim Investigational Site, Murs Erigne, France; Recruiting

502.550.3302A Boehringer Ingelheim Investigational Site, Nantes, France; Recruiting

502.550.3303A Boehringer Ingelheim Investigational Site, Marseille, France; Not yet recruiting

502.550.3304A Boehringer Ingelheim Investigational Site, Marseille, France; Not yet recruiting

502.550.3304F Boehringer Ingelheim Investigational Site, Marseille, France; Recruiting

502.550.3304G Boehringer Ingelheim Investigational Site, Roquevert, France; Not yet recruiting

502.550.3306A Boehringer Ingelheim Investigational Site, Louvigné de Bais, France; Recruiting

502.550.3305C Boehringer Ingelheim Investigational Site, Marseille, France; Not yet recruiting

502.550.3305E Boehringer Ingelheim Investigational Site, Marseille, France; Not yet recruiting

502.550.3305F Boehringer Ingelheim Investigational Site, Marseille, France; Not yet recruiting

502.550.3305I Boehringer Ingelheim Investigational Site, Aix-en-Provence, France; Recruiting

502.550.3305K Boehringer Ingelheim Investigational Site, Martigues, France; Not yet recruiting

502.550.99501 Boehringer Ingelheim Investigational Site, Tbilisi, Georgia; Recruiting

502.550.99502 Boehringer Ingelheim Investigational Site, Tbilisi, Georgia; Recruiting

502.550.99503 Boehringer Ingelheim Investigational Site, Tbilisi, Georgia; Recruiting

502.550.99504 Boehringer Ingelheim Investigational Site, Tbilisi, Georgia; Recruiting

502.550.99505 Boehringer Ingelheim Investigational Site, Tbilisi, Georgia; Recruiting

502.550.99506 Boehringer Ingelheim Investigational Site, Tbilisi, Georgia; Recruiting

502.550.99507 Boehringer Ingelheim Investigational Site, Tbilisi, Georgia; Recruiting

502.550.99508 Boehringer Ingelheim Investigational Site, Tbilisi, Georgia; Recruiting

502.550.82007 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of; Recruiting

502.550.82008 Boehringer Ingelheim Investigational Site, Cheonan, Korea, Republic of; Recruiting

502.550.82009 Boehringer Ingelheim Investigational Site, Daegu, Korea, Republic of; Recruiting

502.550.82012 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of; Recruiting

502.550.82013 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of; Recruiting

502.550.82010 Boehringer Ingelheim Investigational Site, Wonju, Korea, Republic of; Recruiting

502.550.82011 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of; Recruiting

502.550.82003 Boehringer Ingelheim Investigational Site, Gwangju, Korea, Republic of; Recruiting

502.550.82004 Boehringer Ingelheim Investigational Site, Suwon, Korea, Republic of; Recruiting

502.550.82005 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of; Recruiting

502.550.82006 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of; Recruiting

502.550.82001 Boehringer Ingelheim Investigational Site, Goyang, Korea, Republic of; Recruiting

502.550.82002 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of; Recruiting

502.550.40001 Boehringer Ingelheim Investigational Site, Bucharest, Romania; Not yet recruiting

502.550.40002 Boehringer Ingelheim Investigational Site, Baia Mare Maramures, Romania; Not yet recruiting

502.550.40003 Boehringer Ingelheim Investigational Site, Braila, Romania; Not yet recruiting

502.550.40004 Boehringer Ingelheim Investigational Site, Oradea, Romania; Not yet recruiting

502.550.40005 Boehringer Ingelheim Investigational Site, Sibiu, Romania; Not yet recruiting

502.550.40006 Boehringer Ingelheim Investigational Site, Iasi, Romania; Not yet recruiting

502.550.40007 Boehringer Ingelheim Investigational Site, Brasov, Romania; Not yet recruiting

502.550.40008 Boehringer Ingelheim Investigational Site, Tg. Mures, Romania; Not yet recruiting

502.550.40009 Boehringer Ingelheim Investigational Site, Cluj Napoca, Romania; Not yet recruiting

502.550.40010 Boehringer Ingelheim Investigational Site, Bucharest, Romania; Not yet recruiting

502.550.40011 Boehringer Ingelheim Investigational Site, Cluj Napoca, Romania; Not yet recruiting

502.550.40012 Boehringer Ingelheim Investigational Site, Bucharest, Romania; Not yet recruiting

502.550.07001 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation; Not yet recruiting

502.550.07002 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation; Not yet recruiting

502.550.07003 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation; Recruiting

502.550.07004 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation; Recruiting

502.550.07005 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation; Not yet recruiting

502.550.07006 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation; Recruiting

502.550.07007 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation; Recruiting

502.550.07008 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation; Recruiting

502.550.07009 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation; Recruiting

502.550.07010 Boehringer Ingelheim Investigational Site, St.Petersburg, Russian Federation; Recruiting

502.550.01019 Boehringer Ingelheim Investigational Site, Mobile, Alabama, United States; Recruiting

502.550.01008 Boehringer Ingelheim Investigational Site, Athens, Alabama, United States; Recruiting

502.550.01015 Boehringer Ingelheim Investigational Site, Lomita, California, United States; Recruiting

502.550.01003 Boehringer Ingelheim Investigational Site, Colorado Springs, Colorado, United States; Recruiting

502.550.01014 Boehringer Ingelheim Investigational Site, Fort Lauderdale, Florida, United States; Recruiting

502.550.01002 Boehringer Ingelheim Investigational Site, Louisville, Kentucky, United States; Recruiting

502.550.01013 Boehringer Ingelheim Investigational Site, New Orleans, Louisiana, United States; Not yet recruiting

502.550.01009 Boehringer Ingelheim Investigational Site, New Orleans, Louisiana, United States; Recruiting

502.550.01011 Boehringer Ingelheim Investigational Site, New Iberia, Louisiana, United States; Recruiting

502.550.01018 Boehringer Ingelheim Investigational Site, Olive Branch, Mississippi, United States; Recruiting

502.550.01006 Boehringer Ingelheim Investigational Site, St. Louis, Missouri, United States; Recruiting

502.550.01016 Boehringer Ingelheim Investigational Site, Charlotte, North Carolina, United States; Recruiting

502.550.01007 Boehringer Ingelheim Investigational Site, Greensboro, North Carolina, United States; Recruiting

502.550.01005 Boehringer Ingelheim Investigational Site, Cincinnati, Ohio, United States; Recruiting

502.550.01001 Boehringer Ingelheim Investigational Site, Cleveland, Ohio, United States; Recruiting

502.550.01012 Boehringer Ingelheim Investigational Site, San Antonio, Texas, United States; Recruiting

502.550.01020 Boehringer Ingelheim Investigational Site, Houston, Texas, United States; Recruiting

502.550.01017 Boehringer Ingelheim Investigational Site, Houston, Texas, United States; Recruiting

502.550.01010 Boehringer Ingelheim Investigational Site, Fort Worth, Texas, United States; Recruiting

502.550.01004 Boehringer Ingelheim Investigational Site, Arlington, Virginia, United States; Recruiting

Starting date: June 2009
Last updated: October 12, 2009