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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00877929
• Date of registration: 06/02/2009
• Prospective Registration: No
• Primary sponsor: Boehringer Ingelheim
• Public title: Telmisartan Fixed Dose Combination vs Amlodipine in Hypertensive Patients With Type 2 Diabetes Mellitus
• Scientific 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 Type 2 Diabetes Patients With Hypertension.
• Date of first enrolment: February 2009
• Target sample size: 706
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00877929
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Argentina, Korea, Republic of, Mexico, Netherlands, Slovakia, South Africa, Spain, Sweden, United States

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hypertension

Intervention(s)

Drug: Telmisartan 80

Drug: Amlodipine 10

Primary Outcome(s)

Change From Baseline in Trough Seated Systolic Blood Pressure to Week 8 [Time Frame: Baseline, week 8]

Secondary Outcome(s)

SBP Control 140 at Six Weeks [Time Frame: Baseline, week 6]

SBP Control 140 at Two Weeks [Time Frame: Baseline, week 2]

BP Control (SBP<130 mmHg, DBP<80 mmHg) at One Week [Time Frame: Baseline, week 1]

DBP Response at Week Two [Time Frame: Week 2]

BP Control (SBP<130 mmHg, DBP<80 mmHg) at Two Weeks [Time Frame: Baseline, week 2]

BP Control (SBP<140 mmHg, DBP<90 mmHg) at Four Weeks [Time Frame: Baseline, week 4]

BP Control (SBP<140 mmHg, DBP<90 mmHg) at Two Weeks [Time Frame: Baseline, week 2]

Change From Baseline in Trough Seated Systolic Blood Pressure to Week 1 [Time Frame: Baseline, week 1]

SBP Control 130 at Four Weeks [Time Frame: Baseline, week 4]

SBP Control 140 at Four Weeks [Time Frame: Baseline, week 4]

Change From Baseline in Trough Seated Systolic Blood Pressure to Week 2 [Time Frame: Baseline, week 2]

DBP Response at Week Four [Time Frame: Week 4]

SBP Response 130 at Six Weeks [Time Frame: Baseline, week 6]

SBP Response 130 at Two Weeks [Time Frame: Baseline, week 2]

SBP Response 130 at Eight Weeks [Time Frame: Baseline, week 8]

SBP Response 140 at Eight Weeks [Time Frame: Baseline, week 8]

BP Control (SBP<130 mmHg, DBP<80 mmHg) at Four Weeks [Time Frame: Baseline, week 4]

SBP Response 130 at Four Weeks [Time Frame: Baseline, week 4]

SBP Response 140 at Six Weeks [Time Frame: Baseline, week 6]

SBP Response 140 at Two Weeks [Time Frame: Baseline, week 2]

SBP Response 140 at Four Weeks [Time Frame: Baseline, week 4]

Change From Baseline in Trough Seated Systolic Blood Pressure to Week 4 [Time Frame: Baseline, week 4]

Change From Baseline in Trough Seated Systolic Blood Pressure to Week 6 [Time Frame: Baseline, week 6]

Blood Pressure (BP) Control (SBP<140 mmHg, DBP<90 mmHg) at Eight Weeks [Time Frame: Baseline, week 8]

BP Control (SBP<130 mmHg, DBP<80 mmHg) at Six Weeks [Time Frame: Baseline, week 6]

Change From Baseline in Urine Albumin:Creatinine Ratio (UACR) [Time Frame: 8 weeks]

DBP Response at Week One [Time Frame: Week 1]

SBP Response 130 at One Week [Time Frame: Baseline, week 1]

BP Control (SBP<130 mmHg, DBP<80 mmHg) at Eight Weeks [Time Frame: Baseline, week 8]

BP Control (SBP<140 mmHg, DBP<90 mmHg) at One Week [Time Frame: Baseline, week 1]

SBP Control 130 at One Week [Time Frame: Baseline, week 1]

SBP Control 130 at Six Weeks [Time Frame: Baseline, week 6]

SBP Control 130 at Two Weeks [Time Frame: Baseline, week 2]

SBP Control 140 at One Week [Time Frame: Baseline, week 1]

BP Control (SBP<140 mmHg, DBP<90 mmHg) at Six Weeks [Time Frame: Baseline, week 6]

DBP Response at Six Weeks [Time Frame: week 6]

SBP Control 130 at Eight Weeks [Time Frame: Baseline, week 8]

SBP Response 140 at One Week [Time Frame: Baseline, week 1]

Systolic Blood Pressure (SBP) Control 140 at Eight Weeks [Time Frame: Baseline, week 8]

DBP Response at Eight Weeks [Time Frame: Week 8]

Secondary ID(s)

1235.21

2008-000874-19

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 07/06/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00877929