Study of Nifedipine GITS and Candesartan Combination Compared to Monotherapy in Patients With Essential Hypertension

Completed · Phase 2 · Has a placebo group

Conditions studied: Hypertension, Essential

In brief

The purpose of this study is to determine the blood pressure lowering responses of various dose combinations of nifedipine GITS and candesartan as compared to treatment with each component on their own (monotherapy) and placebo (a look-alike tablet without active ingredient). The drugs - nifedipine GITS and candesartan - which are being investigated are currently approved for use in patients with essential hypertension alone or together with other antihypertensive drugs (combination therapy), but the optimal dose of nifedipine GITS and candesartan used together in the treatment of essential hypertension has not been established yet. In this study patients will be treated with various doses of nifedipine GITS and/or candesartan or placebo. These different regimens will be administered once a day and will be assessed based on their blood pressure lowering effects (mean sitting diastolic blood pressure) in subjects with mild to moderate essential hypertension.

Key facts

Study ID

NCT01303783

Run by

Bayer

People needed

1381

Starts

2011-04-01

Expected to finish

2012-05-01

Last updated by the study team

2017-04-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects 18 years or older. Female subjects must be either post-menopausal for one year, surgically sterile, or using an effective contraceptive method. Hormonal contraceptive use is disallowed.
• Subjects must have mild to moderate essential hypertension (Grade 1 and 2 WHO classifications) as measured by calibrated standard sphygmomanometer. (MSDBP of ≥90 mmHg and < 110 mmHg at Visit 1 (placebo run-in), and MSDBP of ≥95 mmHg and < 110 mmHg at visit 2 (randomization)
• Subjects must have an absolute difference in their MSDBP of less than 10 mmHg between Visit 1 (placebo run- in) and Visit 2 (randomization).

You may not qualify if…

• Severe hypertension (Grade 3 WHO classification; MSDBP ≥110 mmHg and/or MSSBP ≥ 180 mmHg)
• Inability to washout of antihypertensive drugs (even if prescribed for another indication) safely for a period of 14 weeks.
• History of hypertensive retinopathy - known Keith-Wagener Grade III or IV
• History of hypertensive encephalopathy
• Cerebrovascular ischemic event (stroke, transient ischemic attack [TIA])within the previous 12 months
• History of intracerebral hemorrhage or subarachnoid hemorrhage
• Evidence of secondary hypertension such as coarchation of the aorta, pheochromocytoms, hypersaldosteronism, etc.
• Type I diabetes mellitus (DM) or poorly controlled DM Type II as evidenced by a glycosylated hemoglobin [HbA1C] of greater than 9% on visit 1.
• Allergies or known intolerance to one of the investigational drugs/drug class or to one of their ingredients
• Any history of heart failure, New York Heart Association (NYHA) classification III or IV
• Severe coronary heart disease as manifest by a history of myocardial infarction or unstable angina in the last 6 months prior to visit 1.
• Clinically significant cardiac valvular disease
• History of malignancy in the last 5 years, excluding basal or skin cancer
• Uncorrected hypokalemia or hyperkalemia: potassium outside 3.0-5.0 mmol/L
• Surgical or medical conditions that might alter the metabolism, excretion or distribution or absorption of any drug
• Gastrointestinal disease or surgery resulting in the potential for malabsorption
• Severe gastrointestinal tract narrowing; kock pouch (ileostomy after proctocolectomy)
• Cholestasis or biliary obstruction or history of pancreatic injury or clinical significant increase of lipase, amylase, or bilirubin.
• Liver disease or AST/ALT levels >3 x ULN
• Renal insufficiency, defined as eGFR of < 50 mL/min (computed using the Cockroft-Gault formula), or on hemodialysis
• Investigation trial participation with receipt of investigational study drug within the last month
• Previous assignment to treatment in this study
• Female subjects who are pregnant or lactating.
• Subjects who have night employment (night shift).
• Subjects with an aortic aneurysm that, in the opinion of the investigator, will be unsuitable to be enrolled in the study.

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Coral Gables, Florida, United States
• Study site — Deerfield Beach, Florida, United States
• Study site — Deerfield Beach, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Valparaiso, Indiana, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Harrisburg, North Carolina, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Salisbury, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Greenville, South Carolina, United States
• Study site — Mt. Pleasant, South Carolina, United States
• Study site — Dallas, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Kenosha, Wisconsin, United States
• Study site — Bahía Blanca, Buenos Aires, Argentina
• Study site — Quilmes, Buenos Aires, Argentina
• Study site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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