Telmisartan/Amlodipine (80/5) vs. Telmisartan/Amlodipine (40/5) vs. Amlodipine 10 or 5 in Resistant Hypertension

Condition(s) targeted: Hypertension

Intervention: fixed dose combination of telmisartan+amlodipine (Drug); fixed dose combination of telmisartan+amlodipine (Drug); amlodipine (Drug)

Phase: Phase 3

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, Email: clintriage@boehringer-ingelheim.com

The primary objectives of this trial are (a) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is superior in reducing blood pressure at eight weeks compared with A5 (b) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is not inferior in reducing blood pressure at eight weeks compared with A10 and (c) to demonstrate that the incidence of oedema on the fixed-dose combination T40/A5 pooled with the fixed-dose combination T80/A5 is superior (less oedema) to A10 in patients who fail to respond adequately to six weeks treatment with A5.

Official title: An Eight-Week Randomized, 4-Arm, Double-Blind Study to Compare the Efficacy and Safety of Combinations of Telmisartan 40mg + Amlodipine 5mg Versus Telmisartan 80mg + Amlodipine 5mg Versus Amlodipine 5mg Versus Amlodipine 10mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 5mg Monotherapy

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

Primary outcome: The co primary endpoints are the change from baseline in DBP and the rate of incidence of oedema adverse events.

Secondary outcome: the change from baseline in seated SBP. the proportion of patients achieving DBP control

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

Criteria:

Inclusion Criteria:

1. patients aged at least 18 years at the date of signing the consent form

2. diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the study

3. failure to respond adequately to six weeks treatment with amlodipine 5 mg monotherapy

4. able to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigator's decision)

5. willing and able to provide written informed consent (in accordance with Good Clinical Practice and local legislation).

Exclusion Criteria:

1. are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study and do not agree to submit to pregnancy testing during participation in the trial. Acceptable methods of birth control include the transdermal patch, oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner.

2. known or suspected secondary hypertension

3. mean seated SBP over 200 mmHg and/or mean seated DBP over 120 mmHg at Visit 1 or 2 or mean seated SBP over 180 mmHg and/or mean seated DBP over 120 mmHg at the end of the run-in period (Visit 3)

4. any clinically significant hepatic impairment (e. g. clinically significant cholestasis, biliary obstructive disorder or hepatic insufficiency)

5. severe renal impairment (e. g. serum creatinine >3. 0 mg/dL or >265 mcmol/L, known creatinine clearance <30mL/min or clinical markers of severe renal impairment)

6. bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post-renal transplant

7. clinically relevant hyperkalaemia

8. uncorrected volume or sodium depletion.

9. primary aldosteronism.

10. hereditary fructose or lactose intolerance

Boehringer Ingelheim Study Coordinator, Email: clintriage@boehringer-ingelheim.com

Boehringer Ingelheim Investigational Site, Bruxelles, Belgium; Recruiting

Boehringer Ingelheim Investigational Site, Tienen-Kumtich, Belgium; Active, not recruiting

Boehringer Ingelheim Investigational Site, Mol, Belgium; Active, not recruiting

Boehringer Ingelheim Investigational Site, Aywaille, Belgium; Active, not recruiting

Boehringer Ingelheim Investigational Site, Turnhout, Belgium; Active, not recruiting

Boehringer Ingelheim Investigational Site, Natoye, Belgium; Active, not recruiting

Boehringer Ingelheim Investigational Site, Linkebeek, Belgium; Active, not recruiting

Boehringer Ingelheim Investigational Site, Tavier, Belgium; Recruiting

Boehringer Ingelheim Investigational Site, Gozee, Belgium; Active, not recruiting

Boehringer Ingelheim Investigational Site, Dour, Belgium; Recruiting

Boehringer Ingelheim Investigational Site, R?dovre, Denmark; Recruiting

Boehringer Ingelheim Investigational Site, Birker?d, Denmark; Recruiting

Boehringer Ingelheim Investigational Site, Vaerl?se, Denmark; Recruiting

Boehringer Ingelheim Investigational Site, Haderslev, Denmark; Recruiting

Boehringer Ingelheim Investigational Site, Vildbjerg, Denmark; Recruiting

Boehringer Ingelheim Investigational Site, Herning, Denmark; Recruiting

Boehringer Ingelheim Investigational Site, Hinnerup, Denmark; Recruiting

Boehringer Ingelheim Investigational Site, TURKU, Finland; Recruiting

Boehringer Ingelheim Investigational Site, Turku, Finland; Recruiting

Boehringer Ingelheim Investigational Site, Joensuu, Finland; Recruiting

Boehringer Ingelheim Investigational Site, Nantes, France; Recruiting

Boehringer Ingelheim Investigational Site, VANNES, France; Recruiting

Boehringer Ingelheim Investigational Site, La Fresnais, France; Recruiting

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

Boehringer Ingelheim Investigational Site, Murs Erigne, France; Recruiting

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

Boehringer Ingelheim Investigational Site, Vihiers, France; Recruiting

Boehringer Ingelheim Investigational Site, Beaucouze, France; Recruiting

Boehringer Ingelheim Investigational Site, Jarny, France; Recruiting

Boehringer Ingelheim Investigational Site, Segre, France; Recruiting

Boehringer Ingelheim Investigational Site, Angers, France; Recruiting

Boehringer Ingelheim Investigational Site, Briollay, France; Recruiting

Boehringer Ingelheim Investigational Site, Longues Jumelles, France; Recruiting

Boehringer Ingelheim Investigational Site, Le Mesnil en Vallee, France; Recruiting

Boehringer Ingelheim Investigational Site, Cholet, France; Recruiting

Boehringer Ingelheim Investigational Site, ORVAULT, France; Recruiting

Boehringer Ingelheim Investigational Site, St Ouen La Rouerie, France; Recruiting

Boehringer Ingelheim Investigational Site, Tinteniac, France; Recruiting

Boehringer Ingelheim Investigational Site, Le Temple de Bretagne, France; Recruiting

Boehringer Ingelheim Investigational Site, St Aubin les Chateaux, France; Recruiting

Boehringer Ingelheim Investigational Site, La Montagne, France; Recruiting

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

Boehringer Ingelheim Investigational Site, Le Bono, France; Recruiting

Boehringer Ingelheim Investigational Site, Louvigne le Bais, France; Recruiting

Boehringer Ingelheim Investigational Site, Saint Pierre Montlimard, France; Recruiting

Boehringer Ingelheim Investigational Site, La Jubaudiere, France; Recruiting

Boehringer Ingelheim Investigational Site, Avrille, France; Recruiting

Boehringer Ingelheim Investigational Site, Les Ponts de CE, France; Recruiting

Boehringer Ingelheim Investigational Site, Grandchamps, France; Recruiting

Boehringer Ingelheim Investigational Site, Mouliherne, France; Not yet recruiting

Boehringer Ingelheim Investigational Site, Nort sur Erdre, France; Recruiting

Boehringer Ingelheim Investigational Site, La Chapelle sur Erdre, France; Recruiting

Boehringer Ingelheim Investigational Site, La Chapelle /s Erdre, France; Recruiting

Boehringer Ingelheim Investigational Site, Thouars, France; Recruiting

Boehringer Ingelheim Investigational Site, Parcay les Pins, France; Recruiting

Boehringer Ingelheim Investigational Site, Loudun, France; Recruiting

Boehringer Ingelheim Investigational Site, Sautron, France; Recruiting

Boehringer Ingelheim Investigational Site, Nevers, France; Recruiting

Boehringer Ingelheim Investigational Site, St Georges de Montaigu, France; Recruiting

Boehringer Ingelheim Investigational Site, St Gildas de Rhuys, France; Recruiting

Boehringer Ingelheim Investigational Site, Garchizy, France; Recruiting

Boehringer Ingelheim Investigational Site, Guerigny, France; Recruiting

Boehringer Ingelheim Investigational Site, NEVRES, France; Recruiting

Boehringer Ingelheim Investigational Site, Daegu, Korea, Republic of; Active, not recruiting

Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of; Active, not recruiting

Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of; Completed

Boehringer Ingelheim Investigational Site, Gangwon-Do, Korea, Republic of; Active, not recruiting

Boehringer Ingelheim Investigational Site, Daejon, Korea, Republic of; Active, not recruiting

Boehringer Ingelheim Investigational Site, Busan, Korea, Republic of; Active, not recruiting

Boehringer Ingelheim Investigational Site, Gwangju, Korea, Republic of; Active, not recruiting

Boehringer Ingelheim Investigational Site, OUDE PEKELA, Netherlands; Recruiting

Boehringer Ingelheim Investigational Site, Musselkanaal, Netherlands; Recruiting

Boehringer Ingelheim Investigational Site, Hoogwoud, Netherlands; Recruiting

Boehringer Ingelheim Investigational Site, Roelofarendsveen, Netherlands; Recruiting

Boehringer Ingelheim Investigational Site, Bennebroek, Netherlands; Recruiting

Boehringer Ingelheim Investigational Site, Nijverdal, Netherlands; Recruiting

Boehringer Ingelheim Investigational Site, Beerzerveld, Netherlands; Recruiting

Boehringer Ingelheim Investigational Site, Voerendaal, Netherlands; Recruiting

Boehringer Ingelheim Investigational Site, ?LESUND, Norway; Recruiting

Boehringer Ingelheim Investigational Site, BERGEN, Norway; Recruiting

Boehringer Ingelheim Investigational Site, Hamar, Norway; Recruiting

Boehringer Ingelheim Investigational Site, OSLO, Norway; Recruiting

Boehringer Ingelheim Investigational Site, Manila, Philippines; Recruiting

Boehringer Ingelheim Investigational Site, Quezon City, Philippines; Recruiting

Boehringer Ingelheim Investigational Site, Pasig City, Philippines; Recruiting

Boehringer Ingelheim Investigational Site, Makati City, Philippines; Recruiting

Boehringer Ingelheim Investigational Site, Pasay City, Philippines; Recruiting

Boehringer Ingelheim Investigational Site, Krugersdorp, South Africa; Not yet recruiting

Boehringer Ingelheim Investigational Site, Pretoria, South Africa; Not yet recruiting

Boehringer Ingelheim Investigational Site, Boksburg, South Africa; Recruiting

Boehringer Ingelheim Investigational Site, Durban, South Africa; Not yet recruiting

Boehringer Ingelheim Investigational Site, Lenasia, South Africa; Recruiting

Boehringer Ingelheim Investigational Site, Cape Town, South Africa; Not yet recruiting

Boehringer Ingelheim Investigational Site, Johannesburg, South Africa; Not yet recruiting

Boehringer Ingelheim Investigational Site, Johannesburg, South Africa; Recruiting

Boehringer Ingelheim Investigational Site, Stockholm, Sweden; Recruiting

Boehringer Ingelheim Investigational Site, Goteborg, Sweden; Recruiting

Boehringer Ingelheim Investigational Site, Rattvik, Sweden; Recruiting

Boehringer Ingelheim Investigational Site, Lule?, Sweden; Recruiting

Boehringer Ingelheim Investigational Site, Kaohsiung, Taiwan; Active, not recruiting

Boehringer Ingelheim Investigational Site, Changhua, Taiwan; Active, not recruiting

Boehringer Ingelheim Investigational Site, Taichung, Taiwan; Active, not recruiting

Boehringer Ingelheim Investigational Site, Hualien City, Taiwan; Active, not recruiting

Boehringer Ingelheim Investigational Site, Coquitlam, British Columbia, Canada; Recruiting

Boehringer Ingelheim Investigational Site, Vancouver, British Columbia, Canada; Recruiting

Boehringer Ingelheim Investigational Site, Mount Pearl, Newfoundland and Labrador, Canada; Recruiting

Boehringer Ingelheim Investigational Site, Bay Roberts, Newfoundland and Labrador, Canada; Recruiting

Boehringer Ingelheim Investigational Site, St. John's, Newfoundland and Labrador, Canada; Recruiting

Boehringer Ingelheim Investigational Site, Sarnia, Ontario, Canada; Recruiting

Boehringer Ingelheim Investigational Site, Ottawa, Ontario, Canada; Recruiting

Boehringer Ingelheim Investigational Site, Hamilton, Ontario, Canada; Recruiting

Boehringer Ingelheim Investigational Site, London, Ontario, Canada; Recruiting

Boehringer Ingelheim Investigational Site, Etobicoke, Ontario, Canada; Recruiting

Boehringer Ingelheim Investigational Site, Corunna, Ontario, Canada; Recruiting

Boehringer Ingelheim Investigational Site, Sainte-Foy, Quebec, Canada; Recruiting

Starting date: October 2007
Last updated: July 28, 2008