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HypertensionPhase 3NCT02969265

An Efficacy and Safety Study Evaluating the Fixed-Dose Combination of Candesartan Plus Amlodipine in Participants With Mild/Moderate Essential Hypertension

A Phase 3 study testing Amlodipine and TCV-116CCB in people with Hypertension, run by Takeda at 25 sites in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of TCV-116CCB (candesartan cilexetil and amlodipine besylate fixed-dose combination) in Chinese participants with mild to moderate hypertension who do not reach target blood pressure following 4 weeks of treatment with amlodipine monotherapy. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hypertension
What is being tested?
Amlodipine and TCV-116CCB
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
25 sitesChina
Study dates
9 May 2017to 26 Jul 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has grade 1 or 2 essential hypertension which is not adequately controlled, as defined by mean, trough, sitting, clinic systolic blood pressure (SBP):
  • ≥155 to <180 mm Hg in participants who have not received any antihypertensive medication in the 14 days prior to Visit 1.
  • ≥145 to ≤170 mm Hg in participants taking 1 antihypertensive medication at Visit 1.
  • ≥140 to <160 mm Hg in participants taking 2 antihypertensive medications at Visit 1.
  • Is willing to discontinue current antihypertensive medications.
  • Entering amlodipine 5 mg monotherapy:
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  • Must have a clinic SBP measurement of 155 to 179 mm Hg inclusive (determined by the mean of 3 sitting, trough, measurements on Day -28, using same arm throughout study) to qualify for entry in to the 4 week single-blind amlodipine 5 mg monotherapy treatment period.
  • At double-blind randomization:
  • Has not achieved target blood pressure (defined as clinic SBP ≥140 mm Hg as determined by the mean of 3 sitting, trough, measurements) following 4 weeks single-blind treatment with amlodipine 5 mg monotherapy at Day 1 prior to randomization to double-blind treatment.

Who cannot join

  • Has clinic SBP ≥180 mm Hg or DBP ≥110 mm Hg.
  • The participant's 3 SBP measurements differ by more than 15 mm Hg (confirmed by a second set of three measurements).
  • Has been randomized/enrolled in an amlodipine or candesartan or candesartan/amlodipine Fixed dose combination study.
  • Has secondary hypertension of any etiology (e.g., renovascular disease documented as the cause of hypertension, pheochromocytoma, Cushing's syndrome).
  • Has any history of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, persistent or permanent atrial fibrillation or transient ischemic attack.
  • Has clinically significant cardiac conduction defects (e.g., third-degree atrioventricular block, sick sinus syndrome).
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  • Has hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease or hypertrophic cardiomyopathy.
  • Has a history of cancer that has not been in remission for at least 5 years prior to the first dose of single-blind amlodipine monotherapy study drug. (This criterion does not apply to those participants with basal cell or Stage 1 squamous cell carcinoma of the skin).
  • Has poorly-controlled type 1 or 2 diabetes mellitus (hemoglobin A1c [HbA1c] >8.0%) at Screening.
  • Has severe renal dysfunction or disease (based on estimated Glomerular filtration rate [GFR] <30 mL/min/1.73m^2) at Screening.
  • Has hypokalemia or hyperkalemia (defined as serum potassium outside of the normal reference range) at Screening.
  • Has an alanine aminotransferase or aspartate aminotransferase level >2.5 times the upper limit of normal, active liver disease, or jaundice at Screening.
  • Works a night (third) shift (defined as 10 PM [2200] to 6 AM [0600]) (Only for participants with ambulatory blood pressure monitoring [ABPM]).
  • Has an upper arm circumference <24 cm or >42 cm (Only for participants with ABPM).
  • Entering amlodipine 5 mg monotherapy period:
  • Has a clinic SBP ≥180 mm Hg or DBP ≥110 mm Hg.
  • Is non-compliant (<80% or >120%) with study medication during the placebo run-in period.
  • Post-single-blind amlodipine 5 mg treatment period:
  • Achieves target blood pressure (defined as clinic SBP<140 mm Hg as determined by the mean of 3 sitting, trough measurements) following 4 weeks single-blind treatment with amlodipine 5 mg monotherapy at Day 1, prior to randomization to double-blind treatment.
  • Has a clinic SBP ≥180 mm Hg or/and DBP ≥110 mm Hg.
  • Is non-compliant (<80% or >120%) with study medication during the amlodipine 5 mg single-blind treatment period.

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

China25 sites

  • Fuwai Hospital

    Beijing, Beijing Municipality, 100037

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • The Xiangya Hospitalof Central South University

    Changsha, Hunan, 410008

  • West China Hospital, Sichuan Univeisity

    Chengdu, Sichuan, 610041

  • The Second Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116027

  • Daqing first hospital

    Daqing, Heilongjiang, 163001

  • The Second Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510120

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550004

  • Sir Run Run Hospital of Zhejiang University

    Hangzhou, Zhejiang, 310016

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

  • The Second Hospital of Lanzhou University

    Lanzhou, Gansu, 730030

  • Taizhou Hospital of Zhejiang Province

    Linhai, Zhejiang, 317000

  • Lishui Hospital of Zhejiang Province

    Lishui, Zhejiang, 323000

  • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

  • the Central Hospital of Xuhui District, Shanghai

    Shanghai, Shanghai Municipality, 200031

  • Shanghai Putuo Center Hospital

    Shanghai, Shanghai Municipality, 200062

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

  • People's Hospital of Liaoning Province

    Shenyang, Liaoning, 110016

  • Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011

  • Jilin Siping Central Hospital

    Siping, Jilin

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • People's Hospital of Wuhan University

    Wuhan, Hubei, 430060

  • First Affiliated Hospital of Xian Jiaotong University

    Xi’an, Shanxi, 710061

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750004

Other trials in China

About this study

Official title: A Phase-3 Randomized, Double-Blind, Parallel-Group Efficacy and Safety Study Evaluating the Fixed-Dose Combination of Candesartan Plus Amlodipine (8/5 mg) in Chinese Subjects With Mild/Moderate Essential Hypertension, Who Do Not Achieve Target Blood Pressure Following Treatment With Amlodipine 5 mg Monotherapy

The purpose of this study is to evaluate the efficacy and safety of TCV-116CCB (candesartan cilexetil and amlodipine besylate fixed-dose combination) in Chinese participants with mild to moderate hypertension who do not reach target blood pressure following 4 weeks of treatment with amlodipine monotherapy.

Read the detailed description

The drug being tested in this study is called TCV-116CCB (candesartan cilexetil and amlodipine besylate fixed-dose combination). This study will look at blood pressure in Chinese participants with grade 1 or 2 essential hypertension.

The study will enroll approximately 370 patients. Prior to the start of study treatment, participants will undergo run-in period of 2 weeks followed by single-blind treatment period of 4 weeks. Upon completion of single-blind treatment period, participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

  • Amlodipine 5 mg
  • TCV-116CCB (Candesartan 8 mg Plus Amlodipine 5 mg)

All participants will be asked to take one tablet/capsule at the same time each day throughout the study up to 8 weeks.

This multicenter trial will be conducted China. The overall time to participate in this study is 19 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone plus a final visit 14 days after receiving their last dose of drug for a follow-up assessment.

Conditions
Hypertension
Being tested
Amlodipine, TCV-116CCB, Amlodipine Placebo, TCV-116CCB Placebo
Keywords
Drug therapy
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmlodipineDrug

    Amlodipine Capsules

  • TCV-116CCBDrug

    TCV-116CCB Tablets

  • Amlodipine PlaceboDrug

    Amlodipine placebo-matching capsules

  • TCV-116CCB PlaceboDrug

    TCV-116CCB 8/5 mg placebo-matching tablets

Study groups in NCT02969265
Study groupRoleWhat they receive
TCV-116CCB (Candesartan 8 mg Plus Amlodipine 5 mg)ExperimentalRun-in Period: TCV-116CCB placebo-matching tablets, orally, once daily along with amlodipine placebo-matching capsules, orally, once daily up to 2 weeks. Single-blind monotherapy treatment period: TCV-116CCB placebo-matching tablets, orally, once daily along with amlodipine 5 mg capsules, orally, once daily up to 4 weeks. Double-blind treatment period: TCV-116CCB 8/5 mg tablets, orally, once daily along with amlodipine placebo-matching capsules, orally, once daily up to 8 weeks.
Receives: Drug: Amlodipine; Drug: TCV-116CCB; Drug: Amlodipine Placebo; Drug: TCV-116CCB Placebo
Amlodipine 5 mgExperimentalRun-in Period: TCV-116CCB placebo-matching tablets, orally, once daily along with amlodipine placebo-matching capsules, orally, once daily up to 2 weeks. Monotherapy treatment period: TCV-116CCB placebo-matching tablets, orally, once daily along with amlodipine 5 mg capsules, orally, once daily up to 4 weeks. Double-blind treatment period: Amlodipine 5 mg capsules, orally, once daily along with TCV-116CCB placebo-matching tablets, orally, once daily up to 8 weeks.
Receives: Drug: Amlodipine; Drug: Amlodipine Placebo; Drug: TCV-116CCB Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure (SBP) at Week 8

    The change between trough SBP measured at Week 8 relative to baseline. It is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.

    Measured: Baseline and Week 8

Secondary outcomes (2)

  1. Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure (DBP) at Week 8

    The change between trough DBP measured at Week 8 relative to baseline. It is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.

    Measured: Baseline and Week 8

  2. Percentage of Participants who Achieved Target Blood Pressure at Week 8

    Target blood pressure is defined as trough, sitting clinic SBP <140 mm Hg, trough, sitting, clinic DBP <90 mm Hg or achieving both trough, sitting clinic SBP (<140 mm Hg) and DBP targets (<90 mm Hg).

    Measured: Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2016 (estimated)
  2. Study start9 May 2017 (estimated)
  3. Primary completion12 Jul 2018 (estimated)
  4. Study completion26 Jul 2018 (estimated)

Why it stopped: Business reasons unrelated to product safety

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02969265
Sponsor's protocol ID
TCV-116CCB_302
Other IDs
U1111-1184-7520, CTR20160750
Status last verified
Jun 2017
First submitted
17 Nov 2016
Last updated
9 Jun 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Amlodipine and TCV-116CCB in people with Hypertension, run by Takeda at 25 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 9 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure (SBP) at Week 8 (time frame: Baseline and Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02969265.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2017.

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Clinical Trial NCT02969265 | AzTrials