Telmisartan and Amlodipine Fixed Dose Combination Trial for the Treatment of Severe Hypertension

Condition(s) targeted: Hypertension

Intervention: telmisartan (Drug); amlodipine (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 following eight weeks of treatment the FDC of telmisartan 80 mg plus amlodipine 10 mg (T80/A10) is superior as first line therapy in reducing mean seated trough cuff SBP compared to the monotherapies of telmisartan 80 mg (T80) and amlodipine 10 mg (A10) in patients with severe hypertension. A key secondary objective is to identify the duration of treatment required to demonstrate the superiority of the FDC over both of the monotherapies.

Official title: An 8-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 80 + Amlodipine 10mg Versus Amlodipine 10 mg Monotherapy as First Line Therapy in Patients With Severe Hypertension (Grade 3).

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

Primary outcome: The primary endpoint for this trial is the change from baseline in the mean seated trough cuff SBP following eight weeks of treatment.

Secondary outcome: Key secondary endpoints for this trial are the change from baseline in the mean seated trough cuff SBP following four and six weeks of treatment (T80/A10 versus T80 and A10) and following one and two weeks of treatment (T80/A5 versus T80 and A5).

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 severe hypertension as defined SBP greater than 180 mmHg and DBP greater than 95 mmHg at randomisation

4. Ability to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigators discretion)

Exclusion Criteria:

1. Pre-menopausal women (last menstruation 1 year prior to signing informed consent) who:

1. are not surgically sterile; or

2. are nursing, or

3. are pregnant, or

4. 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 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 or phaeochromocytoma)

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 mol/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 or >5. 5 mEq/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 six months, myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past three 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 three 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 six months prior to signing the informed consent form

19. Concomitant administration of any medications known to affect BP, except medications allowed by the protocol

20. Any investigational drug therapy within one month of signing the informed consent

21. Known hypersensitivity to any component of the trial drugs (telmisartan, amlodipine, or placebo)

22. History of non-compliance or inability to comply with prescribed medications or protocol procedures

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

1235.20.001 Boehringer Ingelheim Investigational Site, Bourgas, Bulgaria; Recruiting

1235.20.002 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria; Recruiting

1235.20.003 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria; Recruiting

1235.20.004 Boehringer Ingelheim Investigational Site, Stara Zagora, Bulgaria; Recruiting

1235.20.005 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria; Recruiting

1235.20.006 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria; Recruiting

1235.20.007 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria; Recruiting

1235.20.008 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria; Recruiting

1235.20.009 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria; Recruiting

1235.20.051 Boehringer Ingelheim Investigational Site, Plzen, Czech Republic; Recruiting

1235.20.052 Boehringer Ingelheim Investigational Site, Benatky nad Jizerou, Czech Republic; Recruiting

1235.20.053 Boehringer Ingelheim Investigational Site, Praha 5, Czech Republic; Recruiting

1235.20.054 Boehringer Ingelheim Investigational Site, Pribram, Czech Republic; Recruiting

1235.20.055 Boehringer Ingelheim Investigational Site, Slany, Czech Republic; Recruiting

1235.20.057 Boehringer Ingelheim Investigational Site, Strakonice, Czech Republic; Recruiting

1235.20.058 Boehringer Ingelheim Investigational Site, Tabor, Czech Republic; Recruiting

1235.20.059 Boehringer Ingelheim Investigational Site, Cesky Krumlov, Czech Republic; Recruiting

1235.20.101A Boehringer Ingelheim Investigational Site, Albens, France; Recruiting

1235.20.101C Boehringer Ingelheim Investigational Site, Gresy Sur Aix, France; Recruiting

1235.20.101G Boehringer Ingelheim Investigational Site, Le Bourget du Lac, France; Recruiting

1235.20.102A Boehringer Ingelheim Investigational Site, GEMENOS, France; Recruiting

1235.20.102C Boehringer Ingelheim Investigational Site, Gemenos, France; Recruiting

1235.20.102F Boehringer Ingelheim Investigational Site, Arles, France; Recruiting

1235.20.101B Boehringer Ingelheim Investigational Site, Chambery, France; Recruiting

1235.20.101D Boehringer Ingelheim Investigational Site, Chambery, France; Recruiting

1235.20.101E Boehringer Ingelheim Investigational Site, Saint Jean d'Arvey, France; Recruiting

1235.20.101F Boehringer Ingelheim Investigational Site, Saint Alban Leysse, France; Recruiting

1235.20.102B Boehringer Ingelheim Investigational Site, Marseille, France; Recruiting

1235.20.102D Boehringer Ingelheim Investigational Site, Aubagne, France; Recruiting

1235.20.102E Boehringer Ingelheim Investigational Site, Marseille, France; Recruiting

1235.20.103A Boehringer Ingelheim Investigational Site, Beziers, France; Recruiting

1235.20.103C Boehringer Ingelheim Investigational Site, Beziers, France; Recruiting

1235.20.104A Boehringer Ingelheim Investigational Site, Saint Etienne, France; Recruiting

1235.20.104C Boehringer Ingelheim Investigational Site, Saint Etienne, France; Recruiting

1235.20.104D Boehringer Ingelheim Investigational Site, Saint Etienne, France; Recruiting

1235.20.104E Boehringer Ingelheim Investigational Site, Saint Etienne, France; Recruiting

1235.20.104F Boehringer Ingelheim Investigational Site, Saint Etienne, France; Recruiting

1235.20.103E Boehringer Ingelheim Investigational Site, Cournonterral, France; Recruiting

1235.20.103F Boehringer Ingelheim Investigational Site, Beziers, France; Recruiting

1235.20.105A Boehringer Ingelheim Investigational Site, Toulon, France; Recruiting

1235.20.105B Boehringer Ingelheim Investigational Site, St Cyr les Lecques, France; Recruiting

1235.20.105C Boehringer Ingelheim Investigational Site, Toulon, France; Recruiting

1235.20.105D Boehringer Ingelheim Investigational Site, Toulon, France; Recruiting

1235.20.105E Boehringer Ingelheim Investigational Site, Toulon, France; Recruiting

1235.20.106A Boehringer Ingelheim Investigational Site, Bourg des cptes, France; Recruiting

1235.20.106B Boehringer Ingelheim Investigational Site, Mordelles, France; Recruiting

1235.20.106C Boehringer Ingelheim Investigational Site, Rennes, France; Recruiting

1235.20.106D Boehringer Ingelheim Investigational Site, Etrelles, France; Recruiting

1235.20.106E Boehringer Ingelheim Investigational Site, Janze, France; Recruiting

1235.20.106F Boehringer Ingelheim Investigational Site, Louvigne De bais, France; Recruiting

1235.20.107A Boehringer Ingelheim Investigational Site, Ortez, France; Recruiting

1235.20.107B Boehringer Ingelheim Investigational Site, Orthez, France; Recruiting

1235.20.107E Boehringer Ingelheim Investigational Site, Orthez, France; Recruiting

1235.20.107F Boehringer Ingelheim Investigational Site, Salies de Bearn, France; Recruiting

1235.20.107G Boehringer Ingelheim Investigational Site, Orthez, France; Recruiting

1235.20.108A Boehringer Ingelheim Investigational Site, Labarthe Sur Leze, France; Recruiting

1235.20.108B Boehringer Ingelheim Investigational Site, Labarthe sur Leze, France; Recruiting

1235.20.108C Boehringer Ingelheim Investigational Site, Cugnaux, France; Recruiting

1235.20.108E Boehringer Ingelheim Investigational Site, Carbonne, France; Recruiting

1235.20.108F Boehringer Ingelheim Investigational Site, Fenouillet, France; Recruiting

1235.20.109A Boehringer Ingelheim Investigational Site, Rosiers d'Egletons, France; Recruiting

1235.20.109B Boehringer Ingelheim Investigational Site, Brive, France; Recruiting

1235.20.109C Boehringer Ingelheim Investigational Site, Saignes, France; Recruiting

1235.20.109D Boehringer Ingelheim Investigational Site, Saignes, France; Recruiting

1235.20.109F Boehringer Ingelheim Investigational Site, Saint Aulaire, France; Recruiting

1235.20.110A Boehringer Ingelheim Investigational Site, Jarny, France; Withdrawn

1235.20.152 Boehringer Ingelheim Investigational Site, Budapest, Hungary; Recruiting

1235.20.153 Boehringer Ingelheim Investigational Site, Gyongyos, Hungary; Recruiting

1235.20.155 Boehringer Ingelheim Investigational Site, Mosonmagyarovar, Hungary; Recruiting

1235.20.156 Boehringer Ingelheim Investigational Site, Budapest, Hungary; Recruiting

1235.20.157 Boehringer Ingelheim Investigational Site, Miskolc, Hungary; Recruiting

1235.20.158 Boehringer Ingelheim Investigational Site, Budapest, Hungary; Recruiting

1235.20.159 Boehringer Ingelheim Investigational Site, Budapest, Hungary; Recruiting

1235.20.161 Boehringer Ingelheim Investigational Site, Budapest, Hungary; Recruiting

1235.20.154 Boehringer Ingelheim Investigational Site, Miskolc, Hungary; Recruiting

1235.20.201 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of; Recruiting

1235.20.202 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of; Recruiting

1235.20.203 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of; Recruiting

1235.20.204 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of; Recruiting

1235.20.205 Boehringer Ingelheim Investigational Site, Koyang, Korea, Republic of; Recruiting

1235.20.206 Boehringer Ingelheim Investigational Site, Chunan, Korea, Republic of; Recruiting

1235.20.207 Boehringer Ingelheim Investigational Site, Busan, Korea, Republic of; Recruiting

1235.20.251 Boehringer Ingelheim Investigational Site, Targu-Mures, Romania; Recruiting

1235.20.252 Boehringer Ingelheim Investigational Site, Braila, Romania; Recruiting

1235.20.253 Boehringer Ingelheim Investigational Site, Timisoara, Romania; Recruiting

1235.20.254 Boehringer Ingelheim Investigational Site, Iasi, Romania; Recruiting

1235.20.256 Boehringer Ingelheim Investigational Site, Sibiu, Romania; Recruiting

1235.20.258 Boehringer Ingelheim Investigational Site, Timisoara, Romania; Recruiting

1235.20.259 Boehringer Ingelheim Investigational Site, Bucharest, Romania; Recruiting

1235.20.260 Boehringer Ingelheim Investigational Site, Tg. Mures, Romania; Recruiting

1235.20.261 Boehringer Ingelheim Investigational Site, Oradea, Romania; Recruiting

1235.20.262 Boehringer Ingelheim Investigational Site, Bucharest, Romania; Recruiting

1235.20.302 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation; Recruiting

1235.20.303 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation; Recruiting

1235.20.304 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation; Recruiting

1235.20.305 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation; Recruiting

1235.20.306 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation; Recruiting

1235.20.307 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation; Recruiting

1235.20.308 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation; Recruiting

1235.20.310 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation; Recruiting

1235.20.311 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation; Recruiting

1235.20.309 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation; Recruiting

1235.20.301 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation; Recruiting

1235.20.351 Boehringer Ingelheim Investigational Site, Vrable, Slovakia; Recruiting

1235.20.352 Boehringer Ingelheim Investigational Site, Povazska Bystrica, Slovakia; Recruiting

1235.20.353 Boehringer Ingelheim Investigational Site, Kosice, Slovakia; Recruiting

1235.20.354 Boehringer Ingelheim Investigational Site, Rimavska Sobota, Slovakia; Recruiting

1235.20.355 Boehringer Ingelheim Investigational Site, Galanta, Slovakia; Recruiting

1235.20.356 Boehringer Ingelheim Investigational Site, Trnava, Slovakia; Recruiting

1235.20.402 Boehringer Ingelheim Investigational Site, Granada, Spain; Recruiting

1235.20.403 Boehringer Ingelheim Investigational Site, Sevilla, Spain; Recruiting

1235.20.404 Boehringer Ingelheim Investigational Site, Girona, Spain; Recruiting

1235.20.405 Boehringer Ingelheim Investigational Site, Barcelona, Spain; Recruiting

1235.20.406 Boehringer Ingelheim Investigational Site, Barcelona, Spain; Recruiting

1235.20.407 Boehringer Ingelheim Investigational Site, Badalona, Spain; Recruiting

1235.20.408 Boehringer Ingelheim Investigational Site, Barcelona, Spain; Recruiting

1235.20.409 Boehringer Ingelheim Investigational Site, Valencia, Spain; Recruiting

1235.20.410 Boehringer Ingelheim Investigational Site, Barcelona, Spain; Recruiting

1235.20.451 Boehringer Ingelheim Investigational Site, Kharkov, Ukraine; Recruiting

1235.20.452 Boehringer Ingelheim Investigational Site, Lvov, Ukraine; Recruiting

1235.20.453 Boehringer Ingelheim Investigational Site, Kiev, Ukraine; Recruiting

1235.20.454 Boehringer Ingelheim Investigational Site, Kiev, Ukraine; Recruiting

1235.20.455 Boehringer Ingelheim Investigational Site, Kiev, Ukraine; Recruiting

1235.20.456 Boehringer Ingelheim Investigational Site, Kiev, Ukraine; Recruiting

1235.20.457 Boehringer Ingelheim Investigational Site, Kiev, Ukraine; Recruiting

1235.20.458 Boehringer Ingelheim Investigational Site, Kharkov, Ukraine; Recruiting

1235.20.459 Boehringer Ingelheim Investigational Site, Odessa, Ukraine; Recruiting

1235.20.460 Boehringer Ingelheim Investigational Site, Kharkov, Ukraine; Recruiting

1235.20.461 Boehringer Ingelheim Investigational Site, Kiev, Ukraine; Recruiting

1235.20.503 Boehringer Ingelheim Investigational Site, Long Beach, California, United States; Active, not recruiting

1235.20.507 Boehringer Ingelheim Investigational Site, Long Beach, California, United States; Recruiting

1235.20.518 Boehringer Ingelheim Investigational Site, Tustin, California, United States; Active, not recruiting

1235.20.521 Boehringer Ingelheim Investigational Site, Westlake Village, California, United States; Recruiting

1235.20.525 Boehringer Ingelheim Investigational Site, Buena Park, California, United States; Recruiting

1235.20.529 Boehringer Ingelheim Investigational Site, Roseville, California, United States; Active, not recruiting

1235.20.506 Boehringer Ingelheim Investigational Site, Hialeah, Florida, United States; Active, not recruiting

1235.20.508 Boehringer Ingelheim Investigational Site, DeLand, Florida, United States; Recruiting

1235.20.519 Boehringer Ingelheim Investigational Site, Pembroke Pines, Florida, United States; Recruiting

1235.20.523 Boehringer Ingelheim Investigational Site, Port Orange, Florida, United States; Recruiting

1235.20.528 Boehringer Ingelheim Investigational Site, Blue Ridge, Georgia, United States; Recruiting

1235.20.516 Boehringer Ingelheim Investigational Site, North Dartmouth, Massachusetts, United States; Active, not recruiting

1235.20.527 Boehringer Ingelheim Investigational Site, Bay City, Michigan, United States; Completed

1235.20.510 Boehringer Ingelheim Investigational Site, Las Vegas, Nevada, United States; Recruiting

1235.20.512 Boehringer Ingelheim Investigational Site, Albuquerque, New Mexico, United States; Recruiting

1235.20.509 Boehringer Ingelheim Investigational Site, Bronx, New York, United States; Completed

1235.20.511 Boehringer Ingelheim Investigational Site, Kettering, Ohio, United States; Active, not recruiting

1235.20.515 Boehringer Ingelheim Investigational Site, Tulsa, Oklahoma, United States; Active, not recruiting

1235.20.534 Boehringer Ingelheim Investigational Site, Medford, Oregon, United States; Recruiting

1235.20.513 Boehringer Ingelheim Investigational Site, Tipton, Pennsylvania, United States; Active, not recruiting

1235.20.526 Boehringer Ingelheim Investigational Site, Erie, Pennsylvania, United States; Active, not recruiting

1235.20.517 Boehringer Ingelheim Investigational Site, Providence, Rhode Island, United States; Completed

1235.20.520 Boehringer Ingelheim Investigational Site, Houston, Texas, United States; Recruiting

1235.20.522 Boehringer Ingelheim Investigational Site, Carrollton, Texas, United States; Recruiting

1235.20.530 Boehringer Ingelheim Investigational Site, Killeen, Texas, United States; Active, not recruiting

1235.20.505 Boehringer Ingelheim Investigational Site, Saratoga Springs, Utah, United States; Recruiting

1235.20.533 Boehringer Ingelheim Investigational Site, Magna, Utah, United States; Completed

1235.20.535 Boehringer Ingelheim Investigational Site, Draper, Utah, United States; Active, not recruiting

1235.20.537 Boehringer Ingelheim Investigational Site, Tacoma, Washington, United States; Recruiting

1235.20.501 Boehringer Ingelheim Investigational Site, Madison, Wisconsin, United States; Completed

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