Phase 3
Completed N=132
Compare Efficacy and Safety of Telmisartan/Hydrochlorothiazide With Telmisartan/Hydrochlorothiazide Plus Amlodipine
Source: ClinicalTrials.gov NCT01911780 ↗Enrolled (actual)
132
Serious AEs
1.6%
Results posted
Mar 2016
Primary outcomePrimary: Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period. — -8.8; -1.3 mmHg — p=<0.0001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is a multi-centre, randomised, double-blind, active-controlled, parallel-group comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg + hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+ hydrochlorothiazide 12.5 mg (T80/H12.5 mg) in blood pressure lowering effect at week 8, the end of the double-blind period in essential hypertensive patients who fail to respond adequately to telmisartan 80 mg+ hydrochlorothiazide 12.5 mg.
Patients are assigned to one of the two groups after a 6-week open-label run-in period taking T80/H12.5 mg.
In addition the long-term safety of telmisartan 80 mg+ amlodipine 5 mg+ hydrochlorothiazide 12.5 mg will be evaluated in a 52-week extension period.
In the 52-week open label extension period patients who are assigned to the T80/A5/H12.5 mg group continue the T80/A5/H12.5 mg therapy, and patients who are assigned to the T80/ /H12.5 mg group change to the T80/A5/H12.5 mg therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period. |
-8.8; -1.3 | <0.0001 sig |
| SECONDARY Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period. |
-10.6; -2.1 | <0.0001 sig |
| SECONDARY The Percentage of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 8 Weeks of Double-blind Period. |
44.8; 21.9 | 0.0052 sig |
| SECONDARY The Number of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 52 Weeks of Extension Period. |
41; 33; 24; 28 | — |
| SECONDARY Change From Baseline in Mean DBP Pressure at Trough After 52 Weeks of the Extension Period. |
-11.4; -10.0; -10.9; -10.5 | — |
| SECONDARY Change From Baseline in Mean Seated SBP at Trough After 52 Weeks of the Extension Period. |
-14.8; -14.3; -13.6; -15.9 | — |
Eligibility Criteria
Inclusion criteria
- Essential hypertensive patients who have already taking 2 or 3 antihypertensive drugs and mean seated diastolic blood pressure (DBP) must be >=90 and <=114 mmHg and mean seated systolic blood pressure (SBP) must be =<200 mmHg
- Able to stop all current antihypertensive drugs (other than study medication) from Visit 1b through the end of the trial without risk to the patient based on the investigator's opinion
- Age 20 years or older
Exclusion criteria
- Patients with known or suspected secondary hypertension
- Patients with clinically relevant cardiac arrhythmia
- Congestive heart failure with New York Heart Association (NYHA) functional class III-IV
- Patients with recent cardiovascular events
- Patients with recent stroke events
- Patients with a history of sudden deterioration of renal function with angiotensin II receptor blockers or angiotensin converting enzyme inhibitors; or patients with post-renal transplant or post-nephrectomy
- Patients with hepatic and/or renal dysfunction
- Pre-menopausal women who are nursing or pregnant
Data sourced from ClinicalTrials.gov (NCT01911780). 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.