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

NCT ID: NCT00993109

Last Updated: 2014-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2011-05-31

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

Adalat (Nifedipine, BAYA1040)

Intervention Type: DRUG

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

Arm 2

Group Type: ACTIVE_COMPARATOR

Diovan (Valsartan)

Intervention Type: DRUG

Valsartan 160 mg OM (Two Valsartan 80mg tablets)

Interventions

Adalat (Nifedipine, BAYA1040)

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

Intervention Type: DRUG

Diovan (Valsartan)

Valsartan 160 mg OM (Two Valsartan 80mg tablets)

Intervention Type: DRUG

Eligibility Criteria

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:

1. Any anti-hypertensive treatment other than Valsartan 80 mg

2. Cytochrome P450-3A4 inhibitors or inducers

3. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Guangzhou, Guangdong, China

Shijiazhuang, Hebei, China

Changsha, Hunan, China

Changsha, Hunan, China

Nanjing, Jiangsu, China

Nanjing, Jiangsu, China

Shenyang, Liaoning, China

Beijing, , China

Beijing, , China

Shanghai, , China

Donggu, Gwangju Gwang''yeogsi, South Korea

Bucheon-si, Gyeonggido, South Korea

Yangsan, Gyeongsangnam-do, South Korea

Jongno-gu, , South Korea

Junggu, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Countries

China; South Korea

References

Ke YN, Dong YG, Ma SP, Yuan H, Ihm SH, Baek SH; ADVISE study group. Improved blood pressure control with nifedipine GITS/valsartan combination versus high-dose valsartan monotherapy in mild-to-moderate hypertensive patients from Asia: results from the ADVISE study, a randomized trial. Cardiovasc Ther. 2012 Dec;30(6):326-32. doi: 10.1111/1755-5922.12003.

Reference Type: DERIVED

PMID: 23134522 (View on PubMed)

Other Identifiers

ADVISE

Identifier Type: OTHER

Identifier Source: secondary_id

14511

Identifier Type: -

Identifier Source: org_study_id