Aliskiren HCTZ Compared to Amlodipine in Patients With Stage 2 Systolic Hypertension and Diabetes Mellitus

Women left out

• No pregnant women

  Women who were pregnant could not join.

  “Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\> 5 mIU/mL).”

• No breastfeeding moms

  Women who were breastfeeding could not join.

  “Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\> 5 mIU/mL).”

• Had to use birth control

  Women who couldn't or didn't want to use birth control were turned away.

  “…ourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method.”

• No hormonal birth control

  Women on the pill, patch, ring, shot, implant or hormonal IUD could not join.

  “…y the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent. Reliable contraception should be maint…”

• No kidney or liver problems

  Women with kidney or liver problems were turned away.

  “Evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3 x ULN at Visit 1, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt.”

• No heart disease

  Women with heart disease, heart rhythm problems or a past heart attack were turned away.

  “History of hypertensive encephalopathy or heart failure (NYHA Class II-IV).”

• No cancer

  Women with current or past cancer were turned away.

  “History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.”

Study titles and rules are shown in their original English.