The objective of the study is to evaluate the effects of Angeliq on BP over a period of 8 weeks in postmenopausal women who may benefit from hormone replacement therapy (HRT) for the relief of vasomotor symptoms and who have hypertension.

Condition	Treatment or Intervention	Phase
Hypertension Postmenopause	Drug: drospirenone/17B-estradiol (Angeliq)	Phase III

Further Study Details: 

Primary Outcomes: Mean change from Baseline to Week 8 in systolic office blood pressure measured at trough and in 24-hour systolic ambulatory blood pressure measurement (ABPM) blood pressure.
Secondary Outcomes: Mean change from Baseline to Week 8 in diastolic office cuff blood pressure measured at trough and in 24-hour diastolic ABPM blood pressure.
Expected Total Enrollment:  675

Ages Eligible for Study:  45 Years   -   75 Years,  Genders Eligible for Study:  Female

Criteria

Inclusion Criteria:

• Have hypertension
• Are currently taking antihypertensive medications
• Have had natural menopause at least 1 year prior to screening
• Must require hormone therapy in the opinion of the investigator

Blood Pressure Study Information      1-866-801-6900 

Arkansas
      Little Rock,  Arkansas,  72204,  United States; Recruiting
California
      Greenbrae,  California,  94904,  United States; Recruiting
      Long Beach,  California,  90806,  United States; Recruiting
      Westlake Village,  California,  91361,  United States; Recruiting
      Tustin,  California,  92780,  United States; Recruiting
      Santa Ana,  California,  92705,  United States; Recruiting
      Stanford,  California,  94305,  United States; Recruiting
Colorado
      Englewood,  Colorado,  80112,  United States; Recruiting
Florida
      Naples,  Florida,  34102,  United States; Recruiting
      Jacksonville,  Florida,  32116,  United States; Recruiting
      Miami,  Florida,  33165,  United States; Recruiting
      Daytona Beach,  Florida,  32114,  United States; Recruiting
      West Palm Beach,  Florida,  33409,  United States; Recruiting
Georgia
      Savannah,  Georgia,  31405,  United States; Recruiting
Illinois
      Chicago,  Illinois,  60607,  United States; Recruiting
      Arlington Heights,  Illinois,  60005,  United States; Recruiting
Kansas
      Arkansas City,  Kansas,  67005,  United States; Recruiting
      Wichita,  Kansas,  67212,  United States; Recruiting
      Wichita,  Kansas,  67207,  United States; Recruiting
Louisiana
      New Orleans,  Louisiana,  70119,  United States; Recruiting
      New Orleans,  Louisiana,  70118,  United States; Recruiting
Montana
      Billings,  Montana,  59104,  United States; Recruiting
Nevada
      Las Vegas,  Nevada,  89119,  United States; Recruiting
North Carolina
      Winston Salem,  North Carolina,  27103,  United States; Recruiting
      New Bern,  North Carolina,  28562,  United States; Recruiting
Ohio
      Cleveland,  Ohio,  44122,  United States; Recruiting
      Cincinnati,  Ohio,  45236,  United States; Recruiting
South Carolina
      Columbia,  South Carolina,  29201,  United States; Recruiting
Tennessee
      Knoxville,  Tennessee,  37920,  United States; Recruiting
Texas
      Corpus Christi,  Texas,  78411,  United States; Recruiting
      Dallas,  Texas,  75231,  United States; Recruiting
      Dallas,  Texas,  75234,  United States; Recruiting
Virginia
      Arlington,  Virginia,  22203,  United States; Recruiting
Washington
      Seattle,  Washington,  98105,  United States; Recruiting
      Lakewood,  Washington,  98499,  United States; Recruiting
Wisconsin
      Madison,  Wisconsin,  53719,  United States; Recruiting
Czech Republic
      Praha 1,  110 00,  Czech Republic; Recruiting
      Ceske Budejovice,  370 01,  Czech Republic; Recruiting
      Praha 7,  170 00,  Czech Republic; Recruiting
      Kladno,  272 59,  Czech Republic; Recruiting
Poland
      Krakow,  31-128,  Poland; Recruiting
      Lublin,  20-954,  Poland; Recruiting
      Skierniewice,  96-100,  Poland; Recruiting
      Krakow,  31-507,  Poland; Recruiting
Russian Federation
      Moscow,  125101,  Russian Federation; Recruiting
      Moscow,  101953,  Russian Federation; Recruiting
      Moscow,  127018,  Russian Federation; Recruiting
      Moscow,  121309,  Russian Federation; Recruiting
      Moscow,  129327,  Russian Federation; Recruiting
      Moscow,  111539,  Russian Federation; Recruiting
Russian Federation, Russia
      Moscow,  Russia,  117192,  Russian Federation; Recruiting
Ukraine
      Kiev,  03175,  Ukraine; Recruiting
      Kiev,  01151,  Ukraine; Recruiting
      Kiev,  01103,  Ukraine; Recruiting
      Donetsk,  83003,  Ukraine; Recruiting
      Kiev,  01051,  Ukraine; Recruiting
      Odessa,  65014,  Ukraine; Recruiting

Study ID Numbers:  306743
Record last reviewed:  January 2005
Last Updated:  January 24, 2005
Record first received:  January 21, 2005
ClinicalTrials.gov Identifier:  NCT00102141
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08