Telmisartan Fixed Dose Combination vs Amlodipine in Hypertensive Patients With Type 2 Diabetes Mellitus

NCT ID: NCT00877929

Last Updated: 2014-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 706 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28

Brief Summary

To demonstrate that the fixed dose combination of telmisartan and amlodipine is more effective in lowering blood pressure.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Telmisartan 80 / Amlodipine 10

Telmisartan 80 / Amlodipine 5 for two weeks, then forced titration to Telmisartan 80 / Amlodipine 10 Fixed Dose Combination

Group Type: EXPERIMENTAL

Telmisartan 80

Intervention Type: DRUG

Telmisartan 80 mg

Amlodipine 10

Intervention Type: DRUG

Amlodipine 5 for two weeks, then forced titration to Amlodipine 10

Amlodipine 10

Amlodipine 5 for two weeks, then forced titration to Amlodipine 10

Group Type: ACTIVE_COMPARATOR

Amlodipine 10

Intervention Type: DRUG

Amlodipine 5 for two weeks, then forced titration to Amlodipine 10

Interventions

Telmisartan 80

Telmisartan 80 mg

Intervention Type: DRUG

Amlodipine 10

Amlodipine 5 for two weeks, then forced titration to Amlodipine 10

Intervention Type: DRUG

Amlodipine 10

Amlodipine 5 for two weeks, then forced titration to Amlodipine 10

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Hypertension defined as a mean in-clinic seated cuff Systolic Blood Pressure >150 mmHg at Visit 3 (Randomisation visit)

2. Diagnosis of Type 2 diabetes mellitus

3. =18 years of age at the date of signing the informed consent

4. Ability to stop current antihypertensive therapy without unacceptable risk to the patient (investigator's discretion)

5. Ability to provide written informed consent

Exclusion Criteria

1. Pre-menopausal women (last menstruation <=1 year prior to start of run-in period) who:

1. are not surgically sterile; and/or

2. are nursing or pregnant, or

3. are of child-bearing potential and are NOT practicing acceptable means of birth control or do NOT plan to continue practising an acceptable method throughout the study.

The only acceptable methods of birth control are:

• Intrauterine device (IUD);
• Oral contraceptives (started at least three months prior to start of run-in period)
• Implantable or injectable contraceptives and
• Estrogen patch

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, phaeochromocytoma)

4. Mean seated Systolic Blood Pressure (SBP) =180 mm Hg and/or mean seated Diastolic Blood Pressure (DBP) =110 mm Hg during any visit of the screening and placebo run-in periods

5. Patients with Type 1 diabetes mellitus

6. Renal dysfunction as defined by the following laboratory parameters: Serum creatinine >3.0 mg/dL (or >265 µmol /L) or known creatinine clearance <30 mL/min or clinical markers of severe renal impairment

7. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney

8. Clinically relevant hypokalaemia or hyperkalaemia

9. Uncorrected sodium or volume depletion

10. Primary aldosteronism

11. Hereditary fructose intolerance

12. Biliary obstructive disorders (e.g., cholestatis) or hepatic insufficiency

13. Congestive heart failure New York Heart Academy (NYHA) functional class CHF III-IV (Refer to Appendix 10.3)

14. Contraindication 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)

15. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the Investigator

16. Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve

17. Patients whose diabetes has not been stable and controlled for at least the past three months as defined by an HbA1C >10%

18. Patients who have previously experienced symptoms characteristic of angioedema during treatment with Angiotensin Converting Enzyme (ACE) inhibitors or angiotensin-II receptor antagonists

19. History of drug or alcohol dependency within six months prior to signing the informed consent form

20. Concomitant administration of any medications known to affect blood pressure, except medications allowed by the protocol

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

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

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

24. Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Boehringer Ingelheim

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1235.21.901 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

1235.21.907 Boehringer Ingelheim Investigational Site

Tustin, California, United States

1235.21.913 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

1235.21.910 Boehringer Ingelheim Investigational Site

Hollywood, Florida, United States

1235.21.903 Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

1235.21.905 Boehringer Ingelheim Investigational Site

Tucker, Georgia, United States

1235.21.916 Boehringer Ingelheim Investigational Site

Olive Branch, Mississippi, United States

1235.21.915 Boehringer Ingelheim Investigational Site

Hickory, North Carolina, United States

1235.21.906 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

1235.21.902 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

1235.21.904 Boehringer Ingelheim Investigational Site

Penndel, Pennsylvania, United States

1235.21.908 Boehringer Ingelheim Investigational Site

Carrollton, Texas, United States

1235.21.909 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

1235.21.912 Boehringer Ingelheim Investigational Site

Killeen, Texas, United States

1235.21.911 Boehringer Ingelheim Investigational Site

Ettrick, Virginia, United States

1235.21.102 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

1235.21.103 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

1235.21.107 Boehringer Ingelheim Investigational Site

Ramos Mejía, , Argentina

1235.21.101 Boehringer Ingelheim Investigational Site

Santa Fe, , Argentina

1235.21.105 Boehringer Ingelheim Investigational Site

Zárate, , Argentina

1235.21.302 Boehringer Ingelheim Investigational Site

Acapulco, , Mexico

1235.21.304 Boehringer Ingelheim Investigational Site

Aguascalientes, , Mexico

1235.21.301 Boehringer Ingelheim Investigational Site

Guadalajara, , Mexico

1235.21.303 Boehringer Ingelheim Investigational Site

Guadalajara, , Mexico

1235.21.305 Boehringer Ingelheim Investigational Site

Guadalajara, , Mexico

1235.21.306 Boehringer Ingelheim Investigational Site

Guadalajara, , Mexico

1235.21.408 Boehringer Ingelheim Investigational Site

Beek en Donk, , Netherlands

1235.21.401 Boehringer Ingelheim Investigational Site

Hoogwoud, , Netherlands

1235.21.405 Boehringer Ingelheim Investigational Site

Musselkanaal, , Netherlands

1235.21.404 Boehringer Ingelheim Investigational Site

Nijverdal, , Netherlands

1235.21.403 Boehringer Ingelheim Investigational Site

Oude Pekela, , Netherlands

1235.21.409 Boehringer Ingelheim Investigational Site

Roelofarensveen, , Netherlands

1235.21.406 Boehringer Ingelheim Investigational Site

The Hague, , Netherlands

1235.21.407 Boehringer Ingelheim Investigational Site

Voerendaal, , Netherlands

1235.21.402 Boehringer Ingelheim Investigational Site

Wildervank, , Netherlands

1235.21.501 Boehringer Ingelheim Investigational Site

Bratislava, , Slovakia

1235.21.502 Boehringer Ingelheim Investigational Site

Bratislava, , Slovakia

1235.21.503 Boehringer Ingelheim Investigational Site

Bratislava, , Slovakia

1235.21.504 Boehringer Ingelheim Investigational Site

Bratislava, , Slovakia

1235.21.507 Boehringer Ingelheim Investigational Site

Dunajská Streda, , Slovakia

1235.21.509 Boehringer Ingelheim Investigational Site

Martin, , Slovakia

1235.21.505 Boehringer Ingelheim Investigational Site

Nitra, , Slovakia

1235.21.506 Boehringer Ingelheim Investigational Site

Nitra, , Slovakia

1235.21.508 Boehringer Ingelheim Investigational Site

Rimavská Sobota, , Slovakia

1235.21.27005 Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

1235.21.27007 Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

1235.21.27004 Boehringer Ingelheim Investigational Site

Durban, , South Africa

1235.21.27006 Boehringer Ingelheim Investigational Site

Johannesburg, , South Africa

1235.21.27002 Boehringer Ingelheim Investigational Site

Krugersdorp, , South Africa

1235.21.27001 Boehringer Ingelheim Investigational Site

Lenasia, , South Africa

1235.21.27003 Boehringer Ingelheim Investigational Site

Pretoria, , South Africa

1235.21.202 Boehringer Ingelheim Investigational Site

Incheon, , South Korea

1235.21.201 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

1235.21.203 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

1235.21.204 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

1235.21.205 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

1235.21.702 Boehringer Ingelheim Investigational Site

Castellon, , Spain

1235.21.705 Boehringer Ingelheim Investigational Site

Centelles, , Spain

1235.21.703 Boehringer Ingelheim Investigational Site

Sant Adrià Del Besós, , Spain

1235.21.704 Boehringer Ingelheim Investigational Site

Santa Coloma de Gramanet (Barcelona), , Spain

1235.21.706 Boehringer Ingelheim Investigational Site

Santa Coloma de Gramanet, , Spain

1235.21.801 Boehringer Ingelheim Investigational Site

Gothenburg, , Sweden

1235.21.803 Boehringer Ingelheim Investigational Site

Helsingborg, , Sweden

1235.21.804 Boehringer Ingelheim Investigational Site

Lund, , Sweden

1235.21.802 Boehringer Ingelheim Investigational Site

Västerås, , Sweden

Countries

United States; Argentina; Mexico; Netherlands; Slovakia; South Africa; South Korea; Spain; Sweden

Other Identifiers

2008-000874-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1235.21

Identifier Type: -

Identifier Source: org_study_id