Efficacy of Aliskiren Versus Amlodipine in the Treatment of Diabetic Macular Edema - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00768040

Purpose

The purpose of this study is to assess the efficacy of Aliskiren 300 mg once daily versus Amlodipine 10 mg once daily as a therapy for macular edema in hypertensive patients with diabetes using change in central retinal thickness as a primary endpoint.

Condition	Intervention	Phase
Diabetic Macular Edema	Drug: Aliskiren, Amlodipine	Phase IV

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Amlodipine Amlodipine besylate Aliskiren

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Double-Masked, Double-Dummy, Parallel Group, Group Sequential Design Study to Assess the Efficacy of Oral Aliskiren 300 mg Once Daily Versus Oral Amlodipine 10 mg Once Daily in the Treatment of Diabetic Macular Edema

Further study details as provided by Novartis:

Primary Outcome Measures:

Compare changes in macular edema from baseline to week 12 between aliskiren and amlodipine therapy. [ Time Frame: 12 weeks after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare changes in visual acuity from baseline to week 12 between aliskiren and amlodipine treatments [ Time Frame: 12 weeks after treatment ] [ Designated as safety issue: No ]
Investigate the relationships between changes in macular edema with other biomarkers in the renin-angiotensin system (RAS) from baseline to week 12 [ Time Frame: 12 weeks after treatment ] [ Designated as safety issue: No ]
Investigate the proportion of patients with significant reduction in macular edema from baseline to week 12 between aliskiren and amlodipine treatments [ Time Frame: 12 weeks after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	110
Study Start Date:	September 2008
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Aliskiren, Amlodipine Aliskiren 300 mg orally once daily or Amlodipine 10 mg orally once daily
2: Active Comparator	Drug: Aliskiren, Amlodipine Aliskiren 300 mg orally once daily or Amlodipine 10 mg orally once daily

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female patients 18 to 85 years old, with type 1 or type 2 diabetes and hypertension defined as current or prior antihypertensive treatments OR confirmed untreated office blood pressure > 130/80 mmHg at screening
Diabetic macular edema

Exclusion Criteria:

Media opacity in the study eye of sufficient severity to interfere with the necessary retinal evaluations
Any progressive disease of the retina (e.g. uveitis, rod-cone dystrophy) or optic nerve (e.g. glaucoma) other than diabetic retinopathy
Proliferative diabetic retinopathy or severe pre-proliferative diabetic retinopathy that requires laser photocoagulation
Best corrected visual acuity worse than 20/200 in the study eye
Prior intra-ocular surgery in the study eye with the exception of uncomplicated cataract extraction more than 6 months prior to screening
Laser photocoagulation in the study eye within the prior three months
Current use of or likely need for systemic medications known to be toxic to the lens, retina, or optic nerve (e.g., deferoxamine, hydrochloroquine, ethambutaol).
Heavy smokers (> 5 cigarettes/day) are excluded from study participation, however, both light smokers (â‰¤ 5 cigarettes/day) and nonsmokers are allowed
History of drug allergy or intolerance to aliskiren, amlodipine, or other medications used in the study

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768040

Contacts

Contact: Novartis	+41 61 324 1111
Contact: Novartis Investigator Site	+41 61 324 1111

Locations

Denmark
Novartis Investigator Site	Recruiting
Copenhagen, Denmark
Contact: Novartis +41 61 324 1111
Novartis Investigator Site	Recruiting
Odense, Denmark
Contact: Novartis +41 61 324 1111
Novartis Investigator Site	Recruiting
Arhus, Denmark
Contact: Novartis +41 61 324 1111

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Novartis

Novartis Investigator Site

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CSPP100A2244
Study First Received:	October 6, 2008
Last Updated:	October 6, 2008
ClinicalTrials.gov Identifier:	NCT00768040
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Novartis:

Diabetes
Macular edema
Hypertension

Study placed in the following topic categories:

Calcium, Dietary
Signs and Symptoms
Macular Edema
Eye Diseases
Diabetes Mellitus
Retinal Degeneration

Macular Degeneration
Edema
Retinal Diseases
Amlodipine
Retinal degeneration
Hypertension

Additional relevant MeSH terms:

Membrane Transport Modulators
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Calcium Channel Blockers
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009