Phase 3
Completed N=706
Telmisartan Fixed Dose Combination vs Amlodipine in Hypertensive Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT00877929 ↗Enrolled (actual)
706
Serious AEs
1.0%
Results posted
Jun 2011
Primary outcomePrimary: Change From Baseline in Trough Seated Systolic Blood Pressure to Week 8 — -29.0; -22.9 mmHg — p=0.0001
Summary
To demonstrate that the fixed dose combination of telmisartan and amlodipine is more effective in lowering blood pressure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Trough Seated Systolic Blood Pressure to Week 8 |
-29.0; -22.9 | 0.0001 sig |
| SECONDARY Change From Baseline in Trough Seated Systolic Blood Pressure to Week 6 |
-29.7; -22.6 | 0.0001 sig |
| SECONDARY Change From Baseline in Trough Seated Systolic Blood Pressure to Week 4 |
-27.7; -21.1 | 0.0001 sig |
| SECONDARY Change From Baseline in Trough Seated Systolic Blood Pressure to Week 2 |
-22.4; -16.4 | 0.0001 sig |
| SECONDARY Change From Baseline in Trough Seated Systolic Blood Pressure to Week 1 |
-17.5; -12.6 | 0.0001 sig |
| SECONDARY Blood Pressure (BP) Control (SBP<140 mmHg, DBP<90 mmHg) at Eight Weeks |
237; 177 | — |
| SECONDARY BP Control (SBP<140 mmHg, DBP<90 mmHg) at Six Weeks |
245; 168 | — |
| SECONDARY BP Control (SBP<140 mmHg, DBP<90 mmHg) at Four Weeks |
235; 155 | — |
| SECONDARY BP Control (SBP<140 mmHg, DBP<90 mmHg) at Two Weeks |
184; 103 | — |
| SECONDARY BP Control (SBP<140 mmHg, DBP<90 mmHg) at One Week |
130; 72 | — |
| SECONDARY BP Control (SBP<130 mmHg, DBP<80 mmHg) at Eight Weeks |
121; 59 | — |
| SECONDARY BP Control (SBP<130 mmHg, DBP<80 mmHg) at Six Weeks |
134; 60 | — |
| SECONDARY BP Control (SBP<130 mmHg, DBP<80 mmHg) at Four Weeks |
94; 38 | — |
| SECONDARY BP Control (SBP<130 mmHg, DBP<80 mmHg) at Two Weeks |
58; 23 | — |
| SECONDARY BP Control (SBP<130 mmHg, DBP<80 mmHg) at One Week |
35; 12 | — |
| SECONDARY Systolic Blood Pressure (SBP) Control 140 at Eight Weeks |
243; 187 | — |
| SECONDARY SBP Control 140 at Six Weeks |
251; 177 | — |
| SECONDARY SBP Control 140 at Four Weeks |
243; 163 | — |
| SECONDARY SBP Control 140 at Two Weeks |
193; 112 | — |
| SECONDARY SBP Control 140 at One Week |
141; 81 | — |
| SECONDARY SBP Control 130 at Eight Weeks |
157; 89 | — |
| SECONDARY SBP Control 130 at Six Weeks |
164; 81 | — |
| SECONDARY SBP Control 130 at Four Weeks |
137; 70 | — |
| SECONDARY SBP Control 130 at Two Weeks |
92; 42 | — |
| SECONDARY SBP Control 130 at One Week |
50; 26 | — |
| SECONDARY SBP Response 140 at Eight Weeks |
309; 288 | — |
| SECONDARY SBP Response 140 at Six Weeks |
318; 286 | — |
| SECONDARY SBP Response 140 at Four Weeks |
309; 274 | — |
| SECONDARY SBP Response 140 at Two Weeks |
297; 246 | — |
| SECONDARY SBP Response 140 at One Week |
253; 201 | — |
| SECONDARY SBP Response 130 at Eight Weeks |
309; 288 | — |
| SECONDARY SBP Response 130 at Six Weeks |
318; 286 | — |
| SECONDARY SBP Response 130 at Four Weeks |
309; 274 | — |
| SECONDARY SBP Response 130 at Two Weeks |
297; 246 | — |
| SECONDARY SBP Response 130 at One Week |
253; 199 | — |
| SECONDARY DBP Response at Eight Weeks |
253; 214 | — |
| SECONDARY DBP Response at Six Weeks |
275; 214 | — |
| SECONDARY DBP Response at Week Four |
250; 190 | — |
| SECONDARY DBP Response at Week Two |
206; 166 | — |
| SECONDARY DBP Response at Week One |
165; 113 | — |
| SECONDARY Change From Baseline in Urine Albumin:Creatinine Ratio (UACR) |
-0.36; 0.04 | — |
Eligibility Criteria
Inclusion criteria
- Hypertension defined as a mean in-clinic seated cuff Systolic Blood Pressure >150 mmHg at Visit 3 (Randomisation visit)
- Diagnosis of Type 2 diabetes mellitus
- =18 years of age at the date of signing the informed consent
- Ability to stop current antihypertensive therapy without unacceptable risk to the patient (investigator's discretion)
- Ability to provide written informed consent
Exclusion criteria
- Pre-menopausal women (last menstruation 3.0 mg/dL (or >265 µmol /L) or known creatinine clearance 10%
- Patients who have previously experienced symptoms characteristic of angioedema during treatment with Angiotensin Converting Enzyme (ACE) inhibitors or angiotensin-II receptor antagonists
- History of drug or alcohol dependency within six months prior to signing the informed consent form
- Concomitant administration of any medications known to affect blood pressure, except medications allowed by the protocol
- Any investigational drug therapy within one month of signing the informed consent
- Known hypersensitivity to any component of the study drugs (telmisartan, amlodipine, or placebo)
- History of non-compliance or inability to comply with prescribed medications or protocol procedures
- 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
Data sourced from ClinicalTrials.gov (NCT00877929). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.