Evaluation of Potential for Orthostatic Hypotension in Elderly Hypertensives

Completed · Phase 1 · Has a placebo group

Conditions studied: Hypertension

In brief

This is a multi-center, double-blind, randomized, placebo-controlled, 2-session crossover study to evaluate the incidence of orthostatic hypotension in elderly hypertensive subjects following co-administration of carvedilol CR and lisinopril.

Key facts

Study ID

NCT00508365

Run by

GlaxoSmithKline

People needed

62

Starts

2007-09-25

Expected to finish

2008-06-03

Last updated by the study team

2017-08-09

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females who are ≥ 65 years of age
• Body mass index (BMI) between 24 and 37 kg/m2 where: BMI = (weight in kg)/ (height in meters)2
• Subjects must have a documented history of essential hypertension and must be stable on treatment with an ACE inhibitor or angiotensin II receptor antagonist or renin antagonist and no more than one other antihypertensive medication at least 3 months before screening with a sitting SBP<180 mmHg and DBP<110 mmHg.
• All subjects must be able to be safely (in the opinion of the Investigator) withdrawn or down-titrated from all antihypertensive treatment(s) and transitioned to lisinopril 10 mg OD for the two-week run-in phase.

You may not qualify if…

• Any clinically relevant abnormality identified on the screening history, physical or laboratory examination, or any other medical condition or circumstance making the volunteer unsuitable for participation in the study
• Subject who metabolizes carvedilol poorly based on CYP2D6 genotype as determined at screening
• Subject has persistent hyperkalemia or history of hyperkalemia resulting from either Type IV RTA (renal tubular acidosis) or previous treatment with an ACE inhibitor, ARB or renin inhibitor.
• Subject has malignant (accelerated) hypertension, history of malignant hypertension, or history of secondary forms of hypertension
• Subject has advanced hypertensive retinopathy (Keith Wagner Grade IV)
• Subject has a history of hepatic impairment (characterized by prolonged prothrombin time/low concentrations of albumin) and/or renal insufficiency (subjects with an estimated CrCl ≤ 30 mL/min by Cockroft-Gault must be excluded). CrCL = [140-ageCr][weight/70] x 0.85 (if female); Cr in mg/dL; Weight in kg
• Subject is being treated for diabetes mellitus
• Subject has a history of angioedema
• Subject has been under treatment with 3 or more antihypertensive medications. (NOTE: A combination drug containing two antihypertensive agents represents two antihypertensive medications.)
• Subject has been under treatment with HCTZ > 12.5 mg/day
• Subject is receiving ongoing treatment or is anticipated to receive treatment with any of the following medications during the study:
• monoamine oxidase inhibitors (MAO)
• any Class I or III antiarrhythmic
• alpha-adrenergic receptor blockers
• beta-2-adrenergic agonists
• all antidepressants including SSRIs
• lithium
• medications known to be inhibitors/inducers of cytochrome P-450 2D6 should be discontinued for at least 14 days or 5 half-lives [which ever is longer] prior to the first day of the run-in period
• Treatment with any over-the-counter medications , herbal and dietary supplements, as well as grapefruit-containing products within 7 days or 5 half-lives (whichever is longer) prior to first day of run-in period through the end of the study unless approved by the PI and GSK medical monitor. Standard vitamins and/or daily multi-vitamins are permitted, however herbal vitamins should be excluded.
• Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the run-in period
• Subject has mean sitting SBP ≥ 180 mmHg at the screening assessment (one set of repeat measurement is permitted as per approval by the medical monitor).
• Documented history of low blood pressure within six months of screening visit (average sitting SBP < 110 mm Hg and/or DBP /< 50 mm Hg) or blood pressure below these values at time of screening (one set of repeat measurement is permitted as per approval by the medical monitor).
• Orthostatic hypotension diagnosed at screening (orthostatic hypotension is defined as a reduction in systolic blood pressure of 20 mmHg or more and/or a reduction in diastolic blood pressure of 10 mmHg or more for standing vs. supine measurements)
• Subject has any of the following conditions:
• uncontrollable or symptomatic arrhythmias; unstable angina

Where it is running

• GSK Investigational Site — Anniston, Alabama, United States
• GSK Investigational Site — Glendale, Arizona, United States
• GSK Investigational Site — Anaheim, California, United States
• GSK Investigational Site — Beverly Hills, California, United States
• GSK Investigational Site — Long Beach, California, United States
• GSK Investigational Site — Coral Gables, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Sarasota, Florida, United States
• GSK Investigational Site — West Palm Beach, Florida, United States
• GSK Investigational Site — Boise, Idaho, United States
• GSK Investigational Site — Indianapolis, Indiana, United States
• GSK Investigational Site — Las Vegas, Nevada, United States
• GSK Investigational Site — Hackensack, New Jersey, United States
• GSK Investigational Site — Fargo, North Dakota, United States
• GSK Investigational Site — Cleveland, Ohio, United States
• GSK Investigational Site — Oklahoma City, Oklahoma, United States
• GSK Investigational Site — Portland, Oregon, United States
• GSK Investigational Site — Austin, Texas, United States
• GSK Investigational Site — Houston, Texas, United States
• GSK Investigational Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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