NCT00877929
Telmisartan Fixed Dose Combination vs Amlodipine in Hypertensive Patients With Type 2 Diabetes Mellitus
See it on ClinicalTrials.gov ↗706 people
48.3%
51.7%
341 womenmiddle line = equal numbers365 men
- Phase
- PHASE3
- Paid for by
- Boehringer Ingelheim
- Finished
- —
- Health conditions
- Hypertension
- Who could join
- Anyone
- Ages
- 18 Years – no maximum
- Average age
- mean 60.5 years
- Age 65+
- 36.4%
- Weight (BMI)
- mean 63 participants
- Pregnancy recorded
- Not reported
- Menopause recorded
- Not reported
- Results shown by sex
- Not split by sex
- Race
- Black / African American 55.9% · White 38.1% · Asian 5% · American Indian / Alaska Native 0.8% · Native Hawaiian / Pacific Islander 0.1%
Women left out
- No pregnant women
Women who were pregnant could not join.
“are nursing or pregnant, or”
- Had to use birth control
Women who couldn't or didn't want to use birth control were turned away.
“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.”
- No hormonal birth control
Women on the pill, patch, ring, shot, implant or hormonal IUD could not join.
“Oral contraceptives (started at least three months prior to start of run-in period)”
- No kidney or liver problems
Women with kidney or liver problems were turned away.
“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”
- No heart disease
Women with heart disease, heart rhythm problems or a past heart attack were turned away.
“Congestive heart failure New York Heart Academy (NYHA) functional class CHF III-IV (Refer to Appendix 10.3)”
- No diabetes
Women with diabetes were turned away.
“Patients with Type 1 diabetes mellitus”
Study titles and rules are shown in their original English.