Study of the Efficacy and Safety of the Combination of Tw... | NCT01508026

NCT01508026

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nebivolol and Valsartan Fixed Dose Combination 1	Experimental	Fixed Dose Combination Nebivolol 5 mg and Valsartan 80 mg	Drug: Nebivolol and Valsartan 1
Nebivolol and Valsartan Fixed Dose Combination 2	Experimental	Fixed Dose Combination Nebivolol 5 mg and Valsartan 160 mg	Drug: Nebivolol and Valsartan 2
Nebivolol and Valsartan Fixed Dose Combination 3	Experimental	Fixed Dose Combination Nebivolol 10 mg and Valsartan 160 mg	Drug: Nebivolol and Valsartan 3
Nebivolol Low Dose	Experimental	Nebivolol Monotherapy 5 mg	Drug: Nebivolol 1
Nebivolol High Dose	Experimental	Nebivolol Monotherapy 20 mg	Drug: Nebivolol 2
Valsartan Low Dose	Experimental	Valsartan Monotherapy 80 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nebivolol and Valsartan 1	Drug	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

Outcomes Module

Measure	Description	Time Frame
Change in Sitting Diastolic Blood Pressure (DBP)		from basline to Week 8

Measure	Description	Time Frame
Change in Sitting Systolic Blood Pressure (SBP)		from baseline to Week 8

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
David B Bharucha, MD, PhD, FACC	Forest Laboratories	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Forest Investigative Site 1750		Birmingham	Alabama	35216	United States
Forest Investigative Site 1038

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24881993	Derived	Giles TD, Weber MA, Basile J, Gradman AH, Bharucha DB, Chen W, Pattathil M; NAC-MD-01 Study Investigators. Efficacy and safety of nebivolol and valsartan as fixed-dose combination in hypertension: a randomised, multicentre study. Lancet. 2014 May 31;383(9932):1889-98. doi: 10.1016/S0140-6736(14)60614-0.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Ancestor Terms

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D000588	Amines
D001578	Benzopyrans
D011714	Pyrans
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases