Telmisartan 80mg Plus Hydrochlorothiazide 25mg First Line in Moderate or Severe Hypertension (NCT00926289) | Clinical Trial Compass
CompletedPhase 4
Telmisartan 80mg Plus Hydrochlorothiazide 25mg First Line in Moderate or Severe Hypertension
United States894 participantsStarted 2009-06
Plain-language summary
The primary objective of this trial is to demonstrate that the fixed-dose combination of T80/HCTZ25 is superior as first line therapy in reducing seated trough cuff Systolic Blood Pressure(SBP) compared to the monotherapy of T80 in patients with grade 2 or grade 3 hypertension (SBP\>=160 mmHg and Diastolic Blood Pressure(DBP)\>=100 mmHg).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation;
✓. Age 18 years or older;
✓. Patients with grade 2 or grade 3 hypertension as defined SBP\>=160 mmHg and DBP\>=100 mmHg at randomization
✓. Ability to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigator's discretion)
Exclusion criteria
✕. Pre-menopausal women (last menstruation \<=1 year prior to signing informed consent) who: a) are not surgically sterile; or b) are nursing, or c) are pregnant, or d) are of childbearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the trial. The only acceptable methods of birth control are: Intra-Uterine Device (IUD), Oral contraceptives, Implantable or injectable contraceptives, Estrogen patch Hormonal birth control should have been in use for at least three months before the study and continue at least until the next menstrual period after completing the study.
✕. Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 a.m.
✕. Known or suspected secondary hypertension (e.g., renal artery stenosis orphaeochromocytoma)
✕. Renal dysfunction as defined by the following laboratory parameters: Serum creatinine \>3.0 mg/dL (or \>265 umol/L) and/or known creatinine clearance of \<30 ml/min and/or clinical markers of severe renal impairment.
What they're measuring
1
Change From Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) to Week 7