Study of the Efficacy and Safety of the Combination of Two FDA Approved Oral Medications, Nebivolol and Valsartan for Treatment of Stage 1 or 2 Hypertension - Full Text View

Purpose

To evaluate the efficacy and safety of fixed-dose combination of nebivolol and valsartan compared to monotherapy and placebo in patients with stage 1 and stage 2 hypertension.

Condition	Intervention	Phase
Stage 1 Hypertension Stage 2 Hypertension	Drug: Nebivolol and Valsartan 1 Drug: Nebivolol and Valsartan 2 Drug: Nebivolol and Valsartan 3 Drug: Nebivolol 1 Drug: Nebivolol 2 Drug: Valsartan 1 Drug: Valsartan 2 Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Double-blind, Placebo-Controlled, 8-Week Study to Evaluate the Safety and Efficacy of Nebivolol and Valsartan Given as a Fixed Dose Combination in Patients With Stage 1 or 2 Essential Hypertension

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Nebivolol Valsartan Nebivolol Hydrochloride

U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:

Change in Sitting Diastolic Blood Pressure (DBP) [ Time Frame: from basline to Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in Sitting Systolic Blood Pressure (SBP) [ Time Frame: from baseline to Week 8 ] [ Designated as safety issue: No ]

Estimated Enrollment:	7500
Study Start Date:	January 2012
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Nebivolol and Valsartan Fixed Dose Combination 1 Fixed Dose Combination Nebivolol 5 mg and Valsartan 80 mg	Drug: Nebivolol and Valsartan 1 Fixed Dose Combination Nebivolol 5 mg and Valsartan 80 mg, oral administration, then dose doubled at Week 11 to Fixed Dose Combination Nebivolol 10 mg and Valsartan 160 mg, oral administration
Experimental: Nebivolol and Valsartan Fixed Dose Combination 2 Fixed Dose Combination Nebivolol 5 mg and Valsartan 160 mg	Drug: Nebivolol and Valsartan 2 Fixed Dose Combination Nebivolol 5 mg and Valsartan 160 mg, oral administration then dose doubled at Week 11 to Fixed Dose Combination Nebivolol 10 mg and Valsartan 320 mg, oral administration
Experimental: Nebivolol and Valsartan Fixed Dose Combination 3 Fixed Dose Combination Nebivolol 10 mg and Valsartan 160 mg	Drug: Nebivolol and Valsartan 3 Fixed Dose Combination Nebivolol 10 mg and Valsartan 160 mg, oral administration then dose doubled at Week 11 to Fixed Dose Combination Nebivolol 20 mg and Valsartan 320 mg, oral administration
Experimental: Nebivolol Low Dose Nebivolol Monotherapy 5 mg	Drug: Nebivolol 1 Nebivolol Monotherapy 5 mg, oral administration, then dose doubled to at Week 11 to Nebivolol Monotherapy 10 mg, oral administration
Experimental: Nebivolol High Dose Nebivolol Monotherapy 20 mg	Drug: Nebivolol 2 Nebivolol Monotherapy 20 mg, oral administration, then dose doubled to at Week 11 to Nebivolol Monotherapy 40mg, oral administration
Experimental: Valsartan Low Dose Valsartan Monotherapy 80 mg	Drug: Valsartan 1 Valsartan Monotherapy 80 mg, oral administration, then dose doubled to at Week 11 to Valsartan Monotherapy, 160 mg, oral administration
Experimental: Valsartan High Dose Valsartan Monotherapy 160 mg	Drug: Valsartan 2 Valsartan Monotherapy 160 mg, oral administration, then dose doubled to at Week 11 to Valsartan Monotherapy, 320 mg, oral administration
Placebo Comparator: Placebo Dose Matched placebo	Drug: Placebo Dose matched placebo, oral administration

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female outpatients of age 18 years or above
Patients diagnosed with stage 1 or stage 2 essential hypertension
Normal physical examination findings, electrocardiogram (ECG) results and chest x-ray; or abnormal findings judged by the Investigator to be not clinically significant

Exclusion Criteria:

Secondary hypertension or severe hypertension
Clinically significant cardiovascular disease or heart failure
Clinical significant respiratory disease that would prohibit the use of a beta blocker
A medical contraindication to discontinuing a current antihypertensive therapy
History of Type 1 diabetes mellitus
History of Severe Mental Illness except mild depression

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01508026

Show 413 Study Locations

Sponsors and Collaborators

Forest Laboratories

Investigators

Study Director:

Tatjana Lukic, MD, MSc

Forest Laboratories

More Information

No publications provided

Responsible Party:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT01508026 History of Changes
Other Study ID Numbers:	NAC-MD-01
Study First Received:	January 9, 2012
Last Updated:	December 31, 2012
Health Authority:	United States: Food and Drug Administration Canada: Health Canada

Keywords provided by Forest Laboratories:

Stage 1
Stage 2
Hypertension

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Nebivolol
Valsartan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents

Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 16, 2013