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

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Amlodipine 10; Drug: Telmisartan 80

Study type: Interventional

Funder types: Industry

Identifiers

NCT00877929

1235.21

2008-000874-19 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 706 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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706 participants in 2 patient groups

Telmisartan 80 / Amlodipine 10

Experimental group

Description:

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

Treatment:

Drug: Telmisartan 80

Drug: Amlodipine 10

Amlodipine 10

Active Comparator group

Description:

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

Treatment:

Drug: Amlodipine 10