Low-dose Nifedipine-Valsartan Combination Compared to Up-titrated Valsartan Monotherapy in Essential Hypertension

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00993109

Collaborator

(none)

360

Enrollment

Locations

Arms

14.9

Duration (Months)

21.2

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This will be a multi-center, prospective, randomized, open-label, parallel design, two arm comparator trial. In the proposed study, the investigators will compare low-dose combination therapy of Nifedipine GITS/OROS plus Valsartan with up-titrated monotherapy of Valsartan with respect to their blood pressure-decreasing effects in patients with essential hypertension.The study consists of a screening visit, followed by randomization and administration of either Nifedipine GITS/OROS 30 mg in combination with Valsartan 80 mg or Valsartan 160 mg for 12 weeks of treatment.The primary efficacy parameters will be mean SBP and DBP on office BP monitoring at 12 weeks of treatment compared to baseline.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Adalat (Nifedipine, BAYA1040) Drug: Diovan (Valsartan)	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

360 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Randomized,Open-label,Parallel Design Comparator Study of Effect of Nifedipine GITS/OROS (Adalat) 30 mg in Combination With Valsartan (Diovan) 80 mg Compared to Valsartan (Diovan) 160 mg Monotherapy in Patients Whose Blood Pressure is Not Well Controlled by Valsartan 80 mg Alone

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Adalat (Nifedipine, BAYA1040) Nifedipine GITS/OROS 30 mg OM + Valsartan 80 mg OM
Active Comparator: Arm 2	Drug: Diovan (Valsartan) Valsartan 160 mg OM (Two Valsartan 80mg tablets)

Arm

Intervention/Treatment

Experimental: Arm 1

Drug: Adalat (Nifedipine, BAYA1040)

Nifedipine GITS/OROS 30 mg OM + Valsartan 80 mg OM

Active Comparator: Arm 2

Drug: Diovan (Valsartan)

Valsartan 160 mg OM (Two Valsartan 80mg tablets)

Outcome Measures

Primary Outcome Measures

Mean Systolic BP and Diastolic BP on office Blood Pressure monitoring [Baseline and 12 weeks of treatment]

Secondary Outcome Measures

Response rate (>/=10mmHg decrease of office SBP and >/=5mmHg decrease of office DBP) [8 and 12 weeks of treatment]
Control rate (</=140/90 of office BP) [8 and 12 weeks of treatment]
Change in pulse pressure (difference between SBP and DBP) [12 weeks of treatment]
Reduction in Urinary microalbumin excretion(UAE) in patients with microalbuminuria [Baseline and 12 weeks of treatment]
Adverse Event reporting [At the start, every 4 weeks during treatment and at the end of treatment]
Vitals signs [At the start, every 4 weeks during treatment and at the end of treatment]
Laboratory tests [At the start and at the end of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Men and women aged 18 - 75 years
Essential hypertension not well controlled by current low dose (80 mg) valsartan monotherapy for at least 4 weeks. Patients on prior treatment with monotherapy diuretic, ACE-I or beta blocker or an ARB other than valsartan and switched to the current low dose valsartan 80 mg monotherapy for at least 4 weeks are also eligible, provided the hypertension is still not well controlled.
Office systolic blood pressure (sitting) >140 mmHg (sitting for >/= 5 min., no cigarettes and/or coffee/tea for >/=30 min. before BP measurement).
BMI <33 kg/m2

Exclusion Criteria:

Participation in any clinical investigational drug study within the previous 12 weeks
Concomitant treatments with:

Any anti-hypertensive treatment other than Valsartan 80 mg
Cytochrome P450-3A4 inhibitors or inducers
Potassium-sparing diuretics

Severe hypertension (DBP >/= 110 mm Hg and/or SBP >/= 180 mm Hg) and/or evidence of secondary forms of hypertension
Any of the following cardiovascular diseases:
History of cardiovascular shock
Myocardial infarction or unstable angina within the previous 6 months
Severe cardiac valve disease
Past or present severe rhythm or conduction disorder.
Cerebrovascular ischemic event and/or history of intracerebral hemorrhage or subarachnoid hemorrhage (SAH) within the previous 12 months
Type 1 or 2 diabetes mellitus
Proteinuria
Uncorrected hypokalemia or hyperkalemia, sodium depletion and/or hypovolemia
Gastrointestinal disease resulting in the potential for malabsorption and/or severe gastro-intestinal tract narrowing; kock pouch (ileostomy after proctocolectomy)
Cholestasis or biliary obstruction
Liver disease or aspartate aminotransferase (AST) / alanine aminotransferase (ALT) levels >3 x upper limits of normal (ULN)
Renal failure, creatinine level >2.0 mg/dl

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Guangzhou	Guangdong	China	510080
2	Shijiazhuang	Hebei	China	050051
3	Changsha	Hunan	China	410008
4	Changsha	Hunan	China	410013
5	Nanjing	Jiangsu	China	210008
6	Nanjing	Jiangsu	China	210029
7	Shenyang	Liaoning	China	110001
8	Beijing		China	100029
9	Beijing		China	100037
10	Shanghai		China	200025
11	Donggu,	Gwangju Gwang''yeogsi	Korea, Republic of	501757
12	Bucheon-si,	Gyeonggido	Korea, Republic of
13	Yangsan-si	Gyeongnam	Korea, Republic of
14	Jongno-gu		Korea, Republic of
15	Jung-gu		Korea, Republic of
16	Seoul		Korea, Republic of	110-744
17	Seoul		Korea, Republic of	120-752